iBIO has consistently advocated for a fast and efficient approach to Medicare coverage for groundbreaking medical devices and diagnostics that enhance patient outcomes in cases of severe or life-threatening illnesses. We commend CMS for revisiting this vital matter.

While the TCET notice represents a positive step forward, we strongly believe that much more can be done to ensure patients have prompt access to new technologies as soon as the FDA approves them. We also understand that the breadth and extent of the TCET program are limited by the available resources for CMS.

Therefore, in addition to offering recommendations to enhance the current proposal, we are fully committed to collaborating with the Agency, the Administration, and Congress to pass legislation and explore how CMS can leverage its existing authority to expand the TCET program and enable broader beneficiary access to safe and innovative medical technologies.

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