CMS’s new national payment rate and unique reimbursement codes signal a transformative shift in radiotherapy reimbursement, removing barriers to the clinical adoption of RefleXion’s SCINTIX biology-guided radiotherapy. The breakthrough approach, utilizing emissions from cancer cells for precise targeting, now receives fair compensation through the New Technology Ambulatory Payment Classification pathway. The codes C9794 and C9795 address the learning curve, ensuring providers are adequately reimbursed for both planning and delivery. This milestone ushers in an era of autonomous radiotherapy, enhancing accessibility and paving the way for advanced cancer treatment.
RefleXion Medical, Inc., a pioneering therapeutic oncology company, recently revealed a significant milestone in the adoption of its cutting-edge SCINTIX biology-guided radiotherapy, as the Centers for Medicare and Medicaid Services (CMS) has introduced a national payment rate through the New Technology (NT) Ambulatory Payment Classification (APC) pathway. This pathway is specifically designed for innovative procedures not covered by existing reimbursement claims data, providing a critical step toward facilitating the widespread clinical implementation of this groundbreaking cancer treatment option.
Todd Powell, the CEO and president of RefleXion Medical, expressed enthusiasm about this development, emphasizing its profound impact on radiotherapy reimbursement—a domain that has seen minimal positive changes in nearly two decades. Powell stated, “This is the most positive change in radiotherapy reimbursement in nearly 20 years and translates into a significant win for cancer patients.” Recognizing the challenges associated with incorporating novel technologies into clinical practice, Powell stressed the importance of fair compensation for technological innovations, which is essential for healthcare providers to adopt and integrate innovative treatment options effectively.
Acknowledging the potential of SCINTIX therapy for patients with various stages of indicated cancers, Powell expressed gratitude for CMS’s recognition and decisive action in addressing payment barriers that could impede the clinical adoption of this revolutionary cancer treatment modality. The establishment of a national payment rate for SCINTIX therapy is poised to have a transformative effect on the landscape of radiotherapy reimbursement, facilitating greater accessibility to this advanced treatment approach.
The NT APC process, employed by CMS to evaluate novel technologies, considers various criteria to determine their uniqueness. A crucial factor is whether a new procedure can be adequately described using existing reimbursement codes or a combination thereof. In the case of SCINTIX therapy, which utilizes emissions from cancer cells—generated by administering a radiopharmaceutical—to autonomously target cancer during radiotherapy, CMS recognized its unparalleled nature. While other technologies rely on anatomical images to guide radiotherapy delivery, SCINTIX stands out as the sole radiotherapy approach utilizing cancer cell emissions for precision targeting.
In response to the distinctiveness of SCINTIX therapy, CMS has introduced two new reimbursement codes, effective from January 1, 2024. Code C9794 delineates a pre-treatment procedure involving the collection of radiopharmaceutical emissions data for creating the SCINTIX treatment plan. The second code, C9795, pertains to the actual delivery of the SCINTIX treatment plan and is billed after each treatment session. This coding framework not only recognizes the innovative nature of SCINTIX therapy but also addresses the learning curve associated with adopting new technologies by compensating providers for both the planning and delivery phases.
The creation of these reimbursement codes signifies a significant step toward overcoming challenges associated with procedural payment rates for novel technologies. Both codes are expected to retain NT APC status for two to three years, allowing CMS to gather procedural cost data based on actual usage at RefleXion clinical sites across the United States. This data-driven approach ensures that payment rates accurately reflect the resources and efforts involved in delivering SCINTIX therapy, fostering a fair and sustainable reimbursement structure.
SCINTIX therapy stands out as a revolutionary approach to addressing the challenges of targeting and motion management in external beam radiotherapy, particularly for multiple tumors. Designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA) in 2021 for its potential in managing motion in lung tumors, SCINTIX therapy received FDA clearance in 2023 for treating lung and bone tumors arising from primary or metastatic disease. The commencement of patient treatments at various clinical sites in 2023 marked a significant milestone, ushering in a new era of autonomous radiotherapy where the biology of the tumor directs the precise delivery of radiation doses.
Overall, the establishment of a national payment rate by CMS for RefleXion’s SCINTIX therapy represents a pivotal moment in the evolution of radiotherapy reimbursement. This decision not only recognizes the unique attributes of SCINTIX therapy but also addresses payment barriers, fostering a conducive environment for the widespread adoption of this groundbreaking cancer treatment modality. The introduction of specific reimbursement codes reflects a commitment to fair compensation for technological innovation, ensuring that providers are appropriately reimbursed for the planning and delivery phases of SCINTIX therapy. As SCINTIX therapy continues to redefine the landscape of radiotherapy, these developments herald a new era in cancer treatment, where precision and autonomy converge to enhance patient outcomes.
