Comment on CMS-2026-1255-0001

Comment on Prior Authorization and Patient Access to Laboratory Testing To the Centers for Medicare & Medicaid Services RedMoon Project appreciates the opportunity to provide comments regarding prior authorization policies and their impact on patient access to laboratory testing. RedMoon Project is a nonprofit organization dedicated to supporting individuals living with Sickle Cell Disease (SCD) through education, healthcare navigation, mentorship, and optimal wellness initiatives. Through our engagement with patients, caregivers, advocates, and healthcare stakeholders, we regularly hear concerns about barriers that delay access to medically necessary care. We are writing to share our perspective on how prior authorization requirements and administrative barriers can affect access to medically necessary laboratory testing for patients living with chronic and complex health conditions. For many individuals living with Sickle Cell Disease, laboratory testing is not optional. Blood tests are a critical component of disease management and are often used to monitor hemoglobin levels, assess organ function, evaluate treatment effectiveness, identify complications, and guide clinical decision-making. Delays in testing can lead to delays in treatment, increased uncertainty, and potentially preventable health complications. Living with a chronic condition often requires navigating multiple healthcare providers, insurance requirements, and treatment plans. Administrative barriers can create additional stress for patients who are already managing significant health challenges. When testing is delayed, patients may experience anxiety while waiting for answers, uncertainty about their condition, and disruptions to their care plans. RedMoon Project respectfully recommends that CMS consider the following actions: 1. Reduce Prior Authorization Requirements for Routine Disease Monitoring - Patients with chronic conditions often require recurring laboratory testing as part of established standards of care. Routine monitoring tests should be exempted or streamlined whenever possible. 2. Establish Expedited Pathways for Time-Sensitive Testing - Laboratory testing that directly informs treatment decisions should be processed through accelerated review pathways to prevent unnecessary delays in care. 3. Increase Transparency Around Coverage Determinations - Patients and providers should receive clear, understandable explanations when laboratory testing is denied, including information regarding appeal options and alternative pathways. 4. Monitor Health Equity Impacts - CMS should evaluate how prior authorization policies affect populations disproportionately impacted by chronic and rare diseases, including individuals living with Sickle Cell Disease. 5. Support Interoperability and Administrative Simplification - Continued investment in interoperable electronic systems can reduce burdens on providers while improving patient access to medically necessary testing. Many patients with chronic illnesses rely on laboratory testing to help providers make informed decisions about medications, treatment adjustments, and preventive interventions. Timely access to testing can help identify complications early, potentially reducing emergency department visits, hospitalizations, and long-term healthcare costs. We encourage CMS to consider policies that reduce unnecessary administrative barriers to laboratory testing, particularly for patients with chronic and lifelong conditions. Streamlining access to medically necessary testing would support better patient outcomes, improve care coordination, and reduce burdens on both patients and healthcare providers. Thank you for the opportunity to provide feedback on this important issue. Sincerely, Cory Lewis Sickle Cell Warrior, Patient Advocate, and Founder of RedMoon Project