Findings; Sense of Congress

(a) Findings Congress finds the following: (1) According to the Centers for Disease Control and Prevention, in 2021, an estimated 38,400,000 Americans, or 11.6 percent of the entire United States population, have diabetes. (2) The total number of individuals with diabetes is projected to increase to an estimated 54,900,000 individuals by 2030. (3) Diabetes disproportionately impacts the Medicare population, as the Centers for Medicare & Medicaid Services found in 2022, and 26 percent of Medicare beneficiaries have diabetes. (4) Both type 1 and 2 diabetes can significantly harm long-term health and is associated with numerous comorbidities such as cancer, heart disease, chronic kidney disease, blindness, and amputations. (5) The direct and indirect cost of diabetes is significant as the American Diabetes Association found that the total annual cost of diabetes in 2022 was $412,900,000,000, $306,600,000,000 of which is attributable to direct medical costs. (6) The American Diabetes Association and the American Association of Clinical Endocrinology have set forth clinical guidelines that include the use of continuous glucose monitors, insulin pumps, automated insulin delivery systems, and diabetes self-management training for individuals with diabetes. (7) An automated insulin delivery system consists of a continuous glucose monitor, an insulin pump, and an algorithm or software. (8) The algorithm or software is a critical component of an automated insulin delivery system as it continuously learns the user’s behavior and physiological responses and automatically administers the appropriate amount of insulin. (9) Medicare currently fails to separately reimburse for the essential algorithms and software that drive automated insulin delivery (AID) systems, which may stifle future innovation and maintenance, and impede beneficiary access. (10) Medicare has an existing pathway to separately reimburse for the algorithm or software in an automated insulin delivery system, the Medicare durable medical equipment benefit. (11) Including continuous glucose monitors, durable insulin pumps, and related supplies into the competitive bidding program further limits innovation and access to diabetes technologies. (12) The Centers for Medicare & Medicaid Services’ final rule entitled Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies (90 Fed. Reg. 55342 (December 2, 2025)), which reclassifies continuous glucose monitors and durable insulin pumps as items requiring frequent and substantial servicing when they are phased into the competitive bidding program, will have numerous unintended consequences that may prevent Medicare beneficiaries from accessing the continuous glucose monitor or durable insulin pump they need to survive. (b) Sense of Congress regarding automated insulin delivery systems It is the sense of Congress that the Secretary of Health and Human Services should commit to take administrative action to— (1) recognize that the algorithm or software in an automated insulin delivery system is a reasonable and necessary item for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member consistent with Medicare coverage requirements under section 1862(a)(1)(A) of the Social Security Act; (2) ensure the algorithm or software in an automated insulin delivery system is treated as a separately payable supply to durable medical equipment; and (3) when applicable, recognize the algorithm or software in an automated insulin delivery system as medical supplies associated with the injection of insulin consistent with section 1860D–2(e)(1) of the Social Security Act.