CMS’ recent draft guidance on real-world data protocols represents meaningful progress in promoting transparency and rigor in Medicare coverage evaluations. This guidance, centered on the HARPER+ (an adaptation of the HARmonized Protocol Template to Enhance Reproducibility protocol template), provides researchers with a foundation for consistent, high-quality protocol design across regulatory contexts, yet several opportunities for improvement remain.
In an article published in PharmExec.com, Aetion’s Patrick Arena (Director, Science) discusses some key refinements to the HARPER+ template that could improve its practical value and ensure that Medicare coverage decisions are supported by high-quality evidence.