Bill > HR4043

This bill aims to ensure prompt coverage and payment of breakthrough medical devices under the Medicare program. The key provisions are: 1. It establishes a "transitional coverage period" of up to 4 years during which breakthrough devices are deemed reasonable and necessary, approved for additional payments, and eligible for pass-through payments, to facilitate patient access. 2. It requires the Secretary to establish a process for regular coverage of breakthrough devices after the transitional period, including identifying any additional data or evidence needed and developing a proposal for ongoing coverage. 3. It requires the Secretary to promptly assign unique codes for breakthrough devices and update payment systems to recognize those codes on a regular basis. 4. It provides special rules for certain "specified breakthrough devices" that do not fit into existing Medicare benefit categories, allowing the Secretary to use or adjust existing payment methodologies or establish new ones to cover these devices during the transitional period. The overall goal is to expedite coverage and payment for innovative medical technologies that have received expedited FDA review and approval as "breakthrough devices."

Budget and Finance, Health and Social Services

https://www.congress.gov/bill/117th-congress/house-bill/4043/all-info