Overview

Exact Sciences is a provider of diagnostic tests for cancer prevention, early detection, and screening. Cologuard, the first US Food and Drug Administration (FDA) approved multitarget stool DNA test, is a noninvasive colorectal cancer (CRC) screening developed by Exact Sciences.

Our Work

We worked with Exact Sciences to develop and implement an engagement strategy to secure inclusion of Cologuard in the MassHealth Fee Schedule, thereby ensuring payment to Exact Sciences for tests used by Medicaid recipients and expanding access to the screening option not currently available to MassHealth enrollees.

We leveraged our relationships at the Massachusetts Medicaid Office (MassHealth) to gather intelligence on the status of Exact Sciences’ application and the issues that were barriers to final approval, ultimately identifying that the issues were political rather than product-related. We utilized this information to craft our narrative regarding the importance of ensuring MassHealth covered Cologuard and then engaged influencers and decisionmakers in the Legislature and Administration, including those who are considered cancer and colorectal cancer policy champions, as well as stakeholder organizations, such as the American Cancer Society Cancer Action Network (ACS CAN), to raise the profile of the issue with the goal of increasing internal and external pressure for approval.

Results

After successfully garnering increased attention and visibility of the issue, we secured the code for Cologuard, a position in a hearing scheduled by the Executive Office of Health and Human Services (EOHHS) for amended rates for clinical laboratory services, which was critical for the advancement of Cologuard being included as a MassHealth offering. After receiving advance notice of the hearing, we developed a strategy and advised Exact Sciences on the process.

Following the hearing, our team continued to serve as a liaison with EOHHS and MassHealth and Cologuard was ultimately included in the final regulations. We are proud that due to our successful strategy, as of January 1, 2025, MassHealth established coverage of Cologuard as a covered colorectal screening tool for Medicaid patients in Massachusetts.