Alliance Comments on Medical Device Provisions of 21st Century Cures 2.0

The first Twenty-first Century Cures bill was passed into law in 2016, with significant advances in funding for the National Institutes for Health and other key healthcare priorities. In 2021, 21^st Century Cures 2.0 (Cures 2.0) was released in the U.S. House of Representatives.

While Cures 2.0 has not passed into law, several provisions have been adopted in other legislation or been acted upon by federal agencies. Recently, bipartisan champions of Cures 2.0 issued a request for information (RFI) on the progress of these provisions, and whether additional actions are needed to meet the goals of the legislation.

The Alliance provided feedback to the bill’s supporters, noting that while there has been significant progress in a number of areas, Congress needs to act in the area of medical device coverage to better align with provisions in Cures 2.0. Instead, the Centers for Medicare and Medicaid Services proposed the Transitional Coverage for Emerging Technologies (TCET) program which, if finalized as proposed, would create additional barriers to care. Our feedback focuses on these concerns and theurgency of engaging with CMS to ensure key changes are made to the proposed TCET pathway, including remedying the agency’s reliance on coverage with evidence development (CED) coverage restrictions.

To read our comments, click here.