What Sponsors Need to Know About Medicare Coverage Analysis

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The paper highlighted findings from a 33-member task force made up of representatives from cancer centers, industry sponsors, and the National Cancer Institute (NCI).

The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews. With this focus, one of the five key areas identified for improving trial activation was creating Medicare Coverage Analysis (MCA, or National coverage analysis [NCA], as the paper stated) for industry-sponsored trials.

MCA is a systemic process of developing a billing plan for a clinical research study, which provides an in-depth analysis of how all the items and services listed in the clinical research protocol are billed per Medicare-provided guidelines. The MCA determines what a patient’s health insurance plan can cover and what a sponsor must pay for. While the MCA process is a critical step to understanding a study’s true cost, it’s often time-consuming for sites. This ultimately increases timelines for sponsors working to activate a study. For sites and sponsors, this disconnect can cause frustration, which is why connecting the dots between each side’s expectations is so important.

Sites and Sponsors Role with MCA

For sites, an MCA can be a labor-intensive task, and according to the AACI white paper, it can take upward of four weeks to develop and complete. To add to these challenges, most sites have limited skilled resources; our survey of clinical research site professionals found 50% of organizations noted the number of staff was the most frequently identified pain point for both budget negotiation and MCA processes. What’s more, many sites fear allegations of Medicare billing fraud, which can lead to fines or legal issues, if Medicare or a private insurer is improperly billed for study procedures.

Sponsors have historically stayed away from getting involved in the MCA process, letting the responsibility fall to each individual site working on the protocol. Bottlenecks in the sites’ ability to complete the MCA can cause frustrations for sponsors waiting to activate trials and are forced to delay the initiation of budget negotiation.

Once the MCA is completed, sites may identify additional fees for sponsors to pay. This can create additional back-and-forth with sponsors, potentially increasing timelines drastically. As evidenced above, the MCA process is a complicated task for sites to complete and a time-consuming barrier to trial activation timelines for sponsors – though it doesn’t have to be.

Rethinking Study Startup

As a key element of study startup, the MCA process is fundamental to developing a draft budget designed to help both the individual research site and sponsor estimate their expenses on protocol-required items and services. One of the main deliverables and recommendations from AACI is sponsors should provide an MCA (or NCA) for each study to improve budget negotiation timelines. This reduces the duplicative work each site is doing individually and removes one of the major barriers to starting the budget negotiation process sooner.

In order to increase efficiency and accelerate the MCA process, sponsors should meet the call of sites and start providing MCAs. Since completing an MCA takes a specific skillset sponsor teams do not currently have, they should consider leveraging specialized service providers or consultants already possessing the needed expertise. Working with an outside service provider also removes the need to train and retain these resources, allowing sponsor teams to focus on tasks they can’t outsource.

Conclusion

The AACI white paper highlights speeding up clinical trial activation timelines requires a change in mindset and an increased understanding of the process for both sides. To overcome MCA-related challenges, working with experts who can expedite and streamline study startup activities by working directly with sponsors helps immensely. The need to complete MCAs in a timely manner is critical to the success of a clinical trial’s activation, subsequently impacting the timeline for when a patient receives access to therapies.

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