Looking to ensure billing compliance and mitigate risk in research billing for your site? Enter your email below to get in contact with one of our experts at Elevate:
coverage analysis
Ensuring Research Billing Compliance for Your Site
As the landscape of research funding and healthcare billing continues to evolve, ensuring compliance with billing regulations has never been more crucial. Over the past few years, numerous large research institutions have faced substantial fines for Medicare "fraud." While these institutions were likely not engaging in fraudulent activities, they often failed to properly segregate charges related to research patient activity. Typically, these organizations relied on their own physicians to determine which elements of a research protocol should be billed as conventional or routine care, leading to inaccuracies and potential legal repercussions.
Elevate Clinical Research Solutions offers a comprehensive Coverage Analysis solution which provides research institutions with an objective and thorough determination of which elements of a protocol should be billed to private or government payors and which should be paid for by the study sponsor. By referencing industry guidelines and peer-reviewed articles, Elevate ensures billing is compliant and accurate by creating a vital billing compliance tool to mitigate the risk of fraud.
Benefits of outsourcing coverage analysis
Outsourcing Coverage Analysis to a specialized provider like Elevate Clinical Research Solutions offers several key benefits:
Site Customized Collaborative Approach: Elevate’s goal is to provide a billing compliance tool fit for purpose for each institution. This means working closely in a collaborative way with sites to ensure any institutional guidelines/polices are accounted for in the process. Elevate is always happy to provide guidance along the way, whether a site does not have any standard practices in place or is looking to work through new billing challenges. Ultimately, this leads to a consistent process, with the backing of expert knowledge, to improve the efficiency and effectiveness of sites’ billing processes.
Objective Expert Analysis: Utilizing an external provider ensures objectivity in the analysis process. Elevate’s friendly clinical research experts also leverage years of experience in multiple therapeutic areas to complete a thorough coverage analysis. This takes into account all billing considerations, ensures a payor is assigned for each study required item, and each billing determination is supported by documentation to provide a clear useful tool which acts as the basis for site research billing compliance.
Start-up Timeline, Site Resource & Cost Efficiencies: Partnering with Elevate helps reduce overall start-up timelines with shorter Coverage Analysis turnaround times. This valuable time can be given back to sites’ internal teams and prevent backlogs stemming from high study volume periods and/or resource constraints. Often, the cost of Coverage Analysis can be incorporated into the standard administration fees requested in the sponsor budget. This means institutions can benefit from expert analysis without incurring additional expenses, making it a cost-effective solution.
Enhanced Compliance: By ensuring that each required item is appropriately billed to third-party payors, including Medicare, Elevate helps institutions avoid the severe consequences associated with fraudulent billing. This proactive approach to compliance mitigates the risk of fines and legal issues, safeguarding the institution’s reputation and financial stability.
How it works
1.
Submission of study documents
The process begins with the site submitting the study protocol, clinical trial agreement (CTA), informed consent, budget, and other relevant study documents to Elevate.
2.
determination of Qualifying Clinical Trials
Elevate then determines whether the study is a qualifying clinical trial per Medicare guidelines.
3.
review of cta and informed consent
The CTA and informed consent language are reviewed to ensure consistency with the protocol. This review helps to prevent any discrepancies and/or lack of alignment between documents which could lead to billing issues.
4.
Comprehensive coverage analysis
Elevate completes a thorough Coverage Analysis (CA) for all procedures and tests outlined in the study documents. This detailed analysis ensures that each item is correctly assigned to the appropriate payor.
5.
delivery of completed CA
Once the analysis is complete, a copy is provided to the site. This document serves as a comprehensive guide to ensure accurate billing.
6.
Coverage analysis review
Elevate coordinates calls with sites as needed to discuss coverage determinations as well as any site specific considerations.
FAQ’S
-
Coverage Analysis is tool created to outline which elements of a research study should be billed to private or government payors and which should be sponsor paid. It also includes other vital information to help sites' research billing process such as CPT/HCPCS codes, research modifiers, and analysis with citations to support the billing determinations. It ensures compliance with billing regulations and helps avoid the risk of fraudulent billing.
-
Coverage Analysis is essential for ensuring that all procedures and tests in a research protocol have a payor assigned and are accurately billed. It helps institutions avoid fines and legal issues associated with improper billing and ensures compliance with Medicare and other payor guidelines.
-
Elevate’s team uses industry guidelines, peer-reviewed articles, and Medicare policies to support all billing determinations. This approach ensures that each decision is well-documented and compliant with current regulations.
-
Yes, often the cost of Coverage Analysis can be included in the standard administration fees requested in the sponsor budget, making it a cost-effective solution for research institutions.
-
Elevate serves Academic Medical Centers and Universities, Healthcare and Hospital Systems, Dedicated/Independent Research Sites, Multi-Specialty Practices, and Trial/Site Management Organizations.
About Elevate clinical research solutions
Elevate clinical research Solutions serves a wide range of clients, including Academic Medical Centers, Integrated Health Systems, Dedicated Research Sites, Multi-Specialty Practices, and Trial/Site Management Organizations. Our service offerings extend beyond Coverage Analysis and includes budget development and negotiation, contract redline and negotiation, revenue protection, CTMS builds, and research team staffing.
ready to learn more about our coverage analysis service?
Enter your email above to get into contact with one of our experts!