In late 2020, Advarra conducted an anonymous survey to collect site-specific study activation data. This data, reported in the full study activation report, covers a wide range of topics associated with clinical trial activation and startup. Topics included IRB/IBC, regulatory and compliance, and budgeting/finance, to name a few. For the purpose of this blog, we analyzed the information associated with Medicare coverage analysis (MCA).
An MCA identifies all items or services required in a clinical trial and describes what should be billed to Medicare. A proper coverage analysis (CA) outlines any applicable Medicare policy, while also addressing the potential costs which are not reimbursable by Medicare or private insurance. This may include costs the sponsor intends to cover, services bundled into the costs of other services, items provided free of charge without any monetary exchange, etc.
Advarra conducts CAs tailored specifically to your institution’s guidelines. Learn how to streamline the CA process through Advarra’s Coverage Analysis Service.
Within the study activation survey, we asked how personnel identify the sites they work on behalf of academic medical centers/universities (AMCs), independent cancer centers, or health system-based sites. When compared to a question asking whether an MCA is required at a site, respondents answered the following:
- 100% of AMCs complete an MCA for clinical trials
- 51% of non-AMCs (health systems, private research sites) complete an MCA for clinical trials
With this result, it is reasonable to determine that AMCs are more prepared when billing Medicare for research assessments. However, looking at federal clinical trial billing-related lawsuits since 2005, nearly all settlements over one million dollars come from AMCs.
While this connection is surprising, several outside factors show this correlation does not imply causation. Our survey showed 21% of AMCs participated in more than 300 clinical trials per year, while only 6% of non-AMCs (health system-based sites and independent/private/dedicated investigative sites) participated in more than 300 clinical trials per year. AMCs also had a diverse portfolio, actively participating in clinical trials involving a wide range of disease settings.
Because of the high number of active clinical trials across a wide range of disease settings, AMCs appear to be more proactive in regard to billing compliance. This is due to the large portfolio of active studies and opportunity of billing-related oversights, emphasized by the number of federal clinical trial billing-related lawsuits.
When asked about internal pain points associated with MCA development, the top response was the number of available staffing. The second most common result was staff expertise, and staff turnover was the third. Coverage analysis is a difficult topic to learn and perfect. This field of expertise often requires years of experience to ensure the quality of work. Each institution operates in its own specific way, making MCA development that much more of a challenge.
Completing the CA in a timely manner is critical to study activation. The MCA is often required to confirm funding requirements are met, which trickles down to the turnaround times of budget/contract development. The site’s startup funding is then suspended, and more importantly, a patient’s treatment may potentially be delayed. In reference to turnaround times, sites said the following:
- 62% complete an MCA in 14 days or more
- 11% complete an MCA in 7 days or less
This survey also asked sites if they have an in-house team or an outsourced team completing MCA development. While several internal teams indicated they completed MCA turnaround in seven days or less, every respondent who indicated they completed MCA turnaround in 14 days or more did so via in-house operations. By comparison, outsourcing MCA to a professional service such as Advarra’s Coverage Analysis Service, institutions can expect MCA turnaround in 5-7 business days. When the CA is conducted efficiently, sites can move forward on their study activation process.
Performing an MCA is often a direct result of participating in research. We were curious as to whether the cost of performing an MCA was covered under clinical trial budgets and contracts. The survey results found:
- 49% of sites successfully recover the cost of MCA development
*Only 54% of sites request MCA cost recovery from sponsors
This shows that sponsors recognize the need for site MCAs and are willing to provide reimbursement for their efforts. Although half of our respondents stated their costs were not covered, the overwhelming majority of these sites did not request MCA cost recovery from their clinical trial sponsors. If you are curious as to whether the time and effort associated with MCA development may be reimbursed, talk to your sponsor. Again, many sponsors are aware of this billing compliance task and are willing to work with their sites to compensate for their costs.
Internal efficiencies are ever more important in clinical research. The need to complete MCAs in a timely manner is critical to the success of a clinical trial’s activation. Many sites face challenges in this area, regarding both internal staffing and MCA development timelines alike. However, this process is required in order to ensure billing compliance and to outline potential costs not covered by a patient’s insurance. This has been confirmed by sponsors, as many recognize the need for site-specific MCAs and are willing to provide reimbursement for their efforts.
To better understand study activation roadblocks, Advarra asked sites to weigh in on their study activation experiences. Our latest industry report outlines these findings, providing sponsors and sites suggestions and solutions, equipping them with information necessary to streamline and improve the overall study activation process. Access the Report