H.R.5343

Ensures prompt coverage of breakthrough medical devices under Medicare.

The Ensuring Patient Access to Critical Breakthrough Products Act amends the Social Security Act to expedite coverage of breakthrough medical devices under Medicare. It defines "breakthrough device" and mandates the Secretary of Health and Human Services to designate such devices based on specific criteria. The bill ensures a national coverage determination for these devices is made within a 4-year transitional period. It also allows the Secretary to review aberrant billing patterns for these devices and requires annual reporting to Congress on the number of applications and designations.