Irrespective of the LCD outcome, CMS’ recent coverage and payment changes for skin substitutes mean significant revenue loss for many manufacturers. As a result, forward-looking manufacturers are now laser-focused on the speed and quality of evidence generation for both CMS and FDA to maintain/regain revenue:
- With CMS’ short timeline to generate and publish evidence for the DFU/VLU LCD, manufacturers launched a wave of randomized controlled trials (RCTs) and real-world evidence (RWE) studies aimed at securing coverage
- With CMS’ recently finalized proposal to set higher payments for skin substitutes that meet higher FDA evidentiary requirements, manufacturers are now initiating RCTs/RWE for FDA PMA or BLA programs for 510(k) and 361 HCT/P products to regain revenue
Unfortunately, many attempts at RCTs and RWE in the wound care field have not been designed and executed with sufficient rigor for CMS let alone FDA’s significantly more rigorous evidentiary requirements. This is exemplified by the recent LCD, which cited numerous issues with many published RCTs/RWE including high risks of bias, underpowered designs, etc. In Droice’s direct discussions with CMS and MACs, multiple medical directors have further confirmed that they will continue to reject such poorly designed and executed studies and emphasized the need for robust, integrated evidence.
To meet CMS/FDA evidentiary requirements at the requisite speed to tackle these coverage/payment changes, Droice Labs has partnered with several sponsors in wound care to execute integrated evidence generation strategies for getting CMS coverage and/or FDA approvals in the fastest possible way:
- Droice’s AI middleware technologies, Hawk and SuperLineage, drive highly efficient RCTs/RWE that meet CMS/FDA submission standards. Read More: Droice discussion with FDA on its technologies for scalable data quality and traceability in FDA submissions.
- Droice is implementing modern, efficient, wound care-specific study designs that significantly reduce clinical trial durations while maximizing regulatory rigor. Read More: Droice discussion with SMEs from Abbvie, Amgen, and AstraZeneca on designs that reduce duration of RCTs for regulatory submissions.
For many wound care products in the current environment, any delay on high quality clinical evidence will ultimately mean reduced impact for patients and significant financial implications for sponsors in the immediate future if not forever.
Talk to Droice today to partner on an integrated evidence generation program for CMS coverage and FDA approvals.