Crossing the Valley of Death (Part 1)
Ted Cho and Brian J. Miller
July 2025
In their first health policy brief published at the Hoover Institution, Ted Cho, MD, MBA (Fellow, Pediatric ED at Boston Children’s) and Brian Miller, MD, MBA, explore the valley of death, or the gap between FDA approval and Medicare coverage. They note the long history of product innovation, with drugs such as antiretrovirals transforming HIV from a death sentence into a chronic disease, while device innovation has transformed many valve replacements from a surgical procedure necessitating an ICU stay into a short-stay interventional cardiology procedure.
While life sciences advocates have typically advocated for having FDA and CMS regulatory processes adhere to the same standard, we recognize the product regulation and payer technology assessment and coverage analysis represent two distinct albeit at times related functions. In their two part series on the valley of death, they explore separately both CMS and FDA process and policy improvements that would help achieve the goal of helping innovative products traverse the valley of death.
In Part 1, the authors review CMS improvements. Our brief explores the history of Medicare coverage reform dating back to the leadership of Administrator Nancy-Ann DeParle during the Clinton administration, with the establishment of the Medicare Evidence Development & Coverage Advisory Committee, on which I served two terms before joining MedPAC. We then review prior Trump Administration efforts to promote the MCIT pathway, and the Biden Administration’s repeal of MCIT and implementation of TCET.
Our policy brief reviews specific regulatory and administrative oversight actions that CMS could take such as:
- Defining reasonable and necessary in rulemaking
- Improvements in the local coverage decision (LCD) process such as transparency of timeframes, use of MEDCAC technical experts, and other process improvements
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