Date of Award

January 2024

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Joseph S. Ross

Abstract

Our health care system should promote the development and useof innovative medical products, while simultaneously discouraging the marketing and adoption of unsafe or unnecessary products. In the United States, two federal agencies within the Department of Health and Human Services are responsible for administering policies directed toward these aims. The Food and Drug Administration (FDA) evaluates safety and effectiveness for market authorization of medical technologies while the Centers for Medicare & Medicaid Services (CMS) determines whether coverage is “reasonable and necessary” for its beneficiaries. Through a series of three investigations, this thesis evaluates federal policies for the regulation and payment of new medical technologies. First, a qualitative policy analysis and case series (Analysis A) illustrates how FDA’s Breakthrough Devices Program and CMS supplemental payments attempt to promote medical device innovation. Second, a cross-sectional study (Analysis B) examines the evidence available to CMS when evaluating supplemental Medicare payments for new medical technologies used in outpatient settings. Third, a cross-sectional study (Analysis C) explores the evidence referenced within CMS local coverage determinations, which constitute the vast majority of all Medicare payment policy decisions for drugs, biologics, and medical devices.

Comments

This thesis is restricted to Yale network users only. It will be made publicly available on 04/30/2026

Download

Share

COinS