Artificial intelligence (AI) is revolutionizing cancer screening, yet most AI-based programs remain outside the coverage of Medicare and private insurers, posing significant challenges for companies seeking adoption and for patients who could benefit from this technology. Brittany Berry-Pusey, co-founder and COO of Avenda Health, highlights that medical devices typically take up to seven years post-FDA approval to achieve reimbursement, creating a substantial barrier.
The FDA has authorized 882 AI and machine learning-enabled devices and programs, with nearly 600 in radiology alone over the past five years. However, most lack billing codes necessary for reimbursement, requiring patients to pay out of pocket. Despite early successes in enhancing cancer diagnosis and care, insurers demand more data to prove these tools’ efficacy over traditional screening methods before offering coverage.
Avenda Health’s Unfold AI prostate cancer platform exemplifies the intricate process of securing insurance coverage. The platform, approved by the FDA for medical decision support, aids urologists in detecting more cancer cells than traditional MRI screenings and helps in identifying treatments that mitigate side effects like incontinence and impotence. The American Medical Association (AMA) has provided a provisional billing code for Unfold AI, a rare achievement among AI radiology products. Avenda is now working to secure Medicare and insurer coverage, a process that often spans several years.
Dr. William Thorwath, CEO of the American College of Radiology, warns against hasty adoption of AI in healthcare, noting the complexity of AI reimbursement and the unclear value of many current AI platforms to patients and the health system. Medicare and private insurers share this cautious stance. A Centers for Medicare & Medicaid Services spokesperson emphasized the agency’s ongoing assessment of innovative technologies, including AI, to ensure safe and responsible integration.
Past experiences, such as with computer-aided mammography in the late 1990s, which led to false positives and unnecessary biopsies, contribute to the current caution. Dr. Rodrigo Cerda, Chief Medical Officer at Independence Blue Cross, stresses that the effectiveness of new AI programs is yet to be definitively proven.
Radiology provider RadNet, unable to secure insurance reimbursement for its Enhanced Breast Cancer Detection AI screening, charges patients directly, recently reducing the test price from $59 to $40. The company’s AI digital health revenue more than doubled in the first quarter, with patient adoption of AI screening increasing from 25% to 39% of mammogram patients. RadNet aims to eventually convince insurers of AI’s value in cancer detection, paralleling the adoption trajectory of digital breast tomosynthesis.
RadNet is also launching an AI-enhanced prostate MRI screening priced at $250, which may further limit patient access due to affordability issues.
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