What Sponsors Need To Know About Medicare Coverage Analysis

By Mike Neuenfeldt, Senior Director of Professional Services

The Association of American Cancer Institutes (AACI) has recently issued a white paper titled "Enhancing Collaboration for Accelerating Trial Activation Timelines." This document highlights insights drawn from a collaborative effort involving a 33-member task force comprising representatives from cancer centers, industry sponsors, and the National Cancer Institute (NCI).

The task force's primary focus was on three facets of study activation: contract negotiation, budget development, and trial start-up committee evaluations. Within this focus, one of the key areas pinpointed for enhancing trial activation involved the establishment of a Medicare Coverage Analysis (MCA), also referred to as National Coverage Analysis (NCA) as per the paper's definition, for industry-sponsored trials.

MCA involves a systematic process to formulate a billing strategy for a clinical research study. It delves into an in-depth breakdown of how all the components and services outlined in the clinical research protocol are billed following Medicare guidelines. MCA determines the extent of coverage offered by a patient's health insurance plan and the expenses a sponsor must bear.

While MCA is vital for understanding a study's actual costs, it can consume substantial time at sites, leading to delays in study activation for sponsors. Discover ways to bridge this gap between sites and sponsors to better align expectations on both sides and avoid further frustration.