Summary

Adds dialysis-related amyloidosis treatments to Medicare Part B and requires Medicare to pay separately for those treatments and any necessary supplies or services furnished in dialysis facilities. Those treatments are excluded from the bundled ESRD (renal dialysis) prospective payment/comprehensive fee, and Medicare payment must equal 100% of reasonable charges for FDA‑approved treatments and necessary adjuncts, effective on enactment. This change alters how dialysis facilities bill Medicare for these specific treatments: payments move from the ESRD bundle into separate Part B reimbursement, affecting beneficiaries, dialysis providers, and Medicare spending and billing systems.

• Establishes a Part B definition for "treatments for dialysis‑related amyloidosis" covering FDA‑approved items/services and necessary adjuncts in dialysis facilities.
• Requires Medicare Part B to pay separately for these treatments rather than including them in the ESRD prospective payment bundle.
• Sets Medicare payment equal to 100% of reasonable charges for covered dialysis‑related amyloidosis treatments and adjuncts.
• Excludes these treatments from the statutory definition of renal dialysis services used in the ESRD bundled payment.
• Takes effect on enactment, prompting rapid CMS billing and claims system changes.
• Applies only to items and services furnished in freestanding or hospital‑based dialysis facilities.
• Shifts costs from the ESRD bundle to separate Part B payments, likely changing provider revenue flows and Medicare spending patterns.
• Does not appropriate new funds or change Medicare eligibility rules; it changes payment classification and rates.