21st Century Cures Act: A Win for Patients and Innovation
By Scott Whitaker, President and CEO, AdvaMed
Enactment of the 21st Century Cures Act represents the culmination of more than two years of bipartisan work by members of the House and Senate — led by House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Committee Member Diana DeGette (D-CO), and Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA). I am proud of the role that AdvaMed played as a leader in the development and advancement of this important legislation from the very beginning.
The final legislation is very positive for the medtech community. It includes a number of important FDA regulatory reforms from AdvaMed’s Innovation Agenda, led by the breakthrough pathway provision that will improve use of the FDA Expedited Access program. There are also provisions to: raise the humanitarian device exemption cap; establish a process for FDA recognition of international standards; improve selection of experts on FDA advisory panels; update the Class I/II exemption list; allow for the use of central IRBs for device trials; require FDA to update its CLIA-waiver guidance; reinvigorate FDA’s use of the Least Burdensome principle in conducting reviews; clarify FDA regulation of software and certain digital health technologies; and improve the regulation of combination products. The package also provides for $500 million in discretionary appropriations for FDA to implement these and other provisions of the legislation.
There are also delivery system reforms, including language to require greater transparency in local coverage decisions (LCDs), which is a positive step forward on AdvaMed’s work to improve the LCD process. While the legislation includes the expected offset that would move up the effective date of the application of Medicare durable medical equipment (DME) rates to the Medicaid program to Jan. 1, 2018, it also includes a constructive retroactive delay of the application of competitive bidding rates to non-competitively bid areas for DME through the end of this year. This delay mirrors legislation introduced by Rep. Tom Price (R-GA) and Sen. John Thune (R-SD), which AdvaMed has supported.
The 21st Century Cures Act is a win for patients and for medical innovation. Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new life-saving, life-enhancing devices and diagnostics for patients.