In a comment letter to the Centers for Medicare and Medicaid Services (CMS), the Partnership to Improve Patient Care (PIPC) offered feedback on CMS's Proposed Guidance Document for Coverage with Evidence Development (CED).
- CED guidance should promote early and consistent engagement of patients and people with disabilities.
- Patient safeguards should promote health equity, not restrict access to care.
- CED should focus on real world data collection.
- CMS should establish standards for meeting evidence generation requirements.
- CED should clearly acknowledge and abide by the laws barring use of QALYs and similar measures.
"We appreciate CMS’ efforts to provide clarification of its CED authority through updated guidance," wrote PIPC Chair Tony Coelho. "[PIPC] hope[s] that the final guidance will reflect policies that are centered on the needs of patients and people with disabilities, especially those with few options for treatment that stand to benefit most from newly approved treatments by the FDA."