Amends title XVIII of the Social Security Act to improve Medicare beneficiary access to new medical technologies.
Ensures that breakthrough devices are eligible for conditional approval under the Medicare New Technology Add-On Payment (NTAP) Program.
Allows for medical breakthroughs to be provided to Medicare beneficiaries without unnecessary delay.
Breakthrough devices not approved by a specified deadline may be conditionally approved for NTAP for a fiscal year, effective for discharges beginning in the first quarter after receiving such approval, clearance, or authorization.
Defines “breakthrough device” as a medical device designated for expedited development and priority review, and approved, cleared, or authorized for the indication for which the designation was made.
Implementation of this clause shall be budget neutral.
Effective immediately upon enactment and applies to breakthrough devices approved, cleared, or authorized on or after July 1, 2023.