H.R. 4043 was introduced on June 22, 2021 by Congresswoman S. DelBene (D-Wash).  The bill would amend Title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices.  The bill has 33 cosponsors.  

H.R. 4043 would establish a transitional coverage period for breakthrough devices beginning on the date of approval by the Food and Drug Administration (FDA), and ending four years after the date on which the Secretary of Health & Human Services (HHS) updates the relevant payment system to recognize the codes assigned to the breakthrough device.  HHS would be required to assign a unique code for purposes of coverage and payment for the breakthrough device within three months of FDA approval.  Within one year after FDA approval, HHS would be required to identify whether additional data or evidence is required with respect to defining the indications for the device.  Within two years, HHS shall develop a proposal for coverage for specific indications; if no such proposal is developed, then the device would be covered for all indications for which the device was approved by the FDA.

As we previously reported, regulations providing for Medicare coverage of breakthrough devices have been pushed back to December 15, 2021.