Comment on CMS-2026-2377-0002

Dear CMS, I am a practicing allergist-immunologist and Assistant Professor of Medicine at the University of Utah, where I provide comprehensive allergy and immunology care for patients of all ages. As a faculty member in an academic medical center with an Allergy and Immunology Fellowship Program, I care for patients receiving allergen immunotherapy while supervising fellows, residents, and medical students. I appreciate the opportunity to comment on the proposed changes to CPT code 95165. I strongly support CMS adopting the CPT definition of a dose for CPT code 95165 as a single injection prepared from a multidose vial. Medicare’s current definition of a dose as a 1 cc aliquot is inconsistent with CPT coding, current allergy practice, and the terminology used by allergists. Maintaining a Medicare-specific definition creates unnecessary confusion in patient care, physician documentation, trainee education, and billing without improving clinical care. Allergen immunotherapy is highly individualized. The number of doses prepared depends on each patient’s allergen sensitivities, clinically incompatible allergen mixtures, treatment phase, missed injections, adverse reactions, and response to therapy. A fixed 1 cc definition does not accurately represent how allergen immunotherapy is prepared or administered in modern practice. As Medicare beneficiaries comprise an increasing proportion of patients receiving immunotherapy, aligning Medicare policy with CPT would improve consistency, reduce administrative burden, and ensure treatment decisions remain driven by patient needs rather than reimbursement rules. I also urge CMS to eliminate or substantially increase the current 30-unit medically unlikely edit (MUE) for CPT code 95165. Many patients appropriately require multiple separately prepared allergen mixtures because certain extracts cannot be combined in the same vial. The current per-claim limit does not reflect individualized immunotherapy practice and may unnecessarily interfere with medically necessary care. If utilization safeguards are maintained, an annual utilization framework with a medical necessity exception process would better reflect the longitudinal nature of allergen immunotherapy. Thank you for considering these comments. Adopting the CPT definition of a dose and addressing the current MUE limitations would better align Medicare policy with contemporary allergy practice while improving access to safe, individualized allergen immunotherapy for Medicare beneficiaries. Sincerely, Mili Shum, MD Assistant Professor of Medicine Division of Allergy & Immunology University of Utah