Employees at Elevate Clinical Research Solutions working on coverage analysis

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coverage analysis

Doctor at a clinical research site choosing Elevate as their vendor for 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.

Coverage Analysis
Coverage Analysis

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.

Coverage Analysis

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.

Coverage Analysis

How it works

Employees completing coverage analysis

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.

Elevate employee determining if a clients study is a qualifying trial

2.

determination of Qualifying Clinical Trials  

Elevate then determines whether the study is a qualifying clinical trial per Medicare guidelines.

Elevate employee shaking hands with a coverage analysis client

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.

Elevate employees working on documents related to coverage analysis

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.

Elevate employees emailing a completed coverage analysis to a client

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.

Elevate reviewing the coverage analysis with a clinical trial client

6.

Coverage analysis review

Elevate coordinates calls with sites as needed to discuss coverage determinations as well as any site specific considerations.

Coverage Analysis Objectives

At Elevate Clinical Research Solutions, each coverage analysis is conducted with a consistent, compliant framework that aligns with federal regulations and industry best practices. Our review objectives include: 

  • Evaluate whether the study qualifies as a Qualifying Clinical Trial (QCT) under the Centers for Medicare & Medicaid Services (CMS) guidelines. This includes assessing whether the trial meets all criteria for billing certain routine services to insurance payers, in accordance with applicable federal laws and regulations.

  • Clearly document who is financially responsible for each patient care cost outlined in the study protocol. Each service is classified as either billable to Medicare or covered by the study sponsor (e.g., the pharmaceutical company) based on the results of the coverage analysis. This ensures transparent and compliant billing practices for all research-related procedures. 

  • Items and services that may be billable to the participant and/or their insurer(s), consistent with Medicare guidance and site-specific policies.

  • Items and services provided solely for research purposes, which should be covered by the sponsor, grant, or institutional funds.

  • Evaluate applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) to support and justify routine cost designations. All determinations are clearly documented to support audit readiness and ensure payer compliance.

  • We ensure each coverage analysis is tailored not only to federal billing regulations, but also to institutional policies, sponsor expectations, and internal workflows. This alignment improves downstream efficiency in budgeting, contracting, and billing operations, reducing the risk of compliance errors and revenue loss.

By adhering to this rigorous, standardized approach, Elevate ensures that your coverage analysis is defensible, transparent, and ready for immediate use across your study start-up process. 

How Does Non-Compliance in Clinical Trial Billing Happen?

Non-compliance in clinical research billing is rarely intentional. More often, it stems from gaps in education, unclear processes, and a lack of alignment between clinical, financial, and research departments. When roles are siloed or billing guidelines misunderstood, even well-intentioned research teams can unknowingly submit inaccurate claims—putting sites at risk for audits, financial penalties, and reputational harm. 

  • Lack of Education and Training

    Many clinical and billing professionals receive limited training on the intricacies of billing for research-related services. Without a clear understanding of federal guidelines (such as Medicare’s Clinical Trial Policy), mistakes in cost assignment and documentation can easily occur.

  • Inadequate Coverage Analysis

    When a robust coverage analysis is not conducted—or not properly integrated into billing workflows—sites risk misclassifying routine care versus research-related costs. This can result in improper billing to insurance payers or sponsors and may lead to violations of the Medicare Secondary Payer (MSP) rule, exposing sites to compliance risks and potential financial penalties.

  • Failure to Use Research Identifiers

    Claims for qualifying clinical trials must include specific research identifiers, such as the NCT# (National Clinical Trial Number), appropriate research diagnosis codes, and required modifiers (e.g., Q0 and Q1), along with the correct condition codes. Omitting or misapplying these can trigger compliance issues and may result in violations of the Medicare Secondary Payer (MSP) rule, putting the site at risk for denied claims or audits.

  • Disconnection Between Departments

    Billing compliance in clinical trials requires close collaboration between research staff, finance teams, and providers. When documentation and communication break down, billing discrepancies are more likely to occur.

  • Insufficient Sponsor Transparency

    If a sponsor’s budget or protocol lacks clarity on what will be required, sites may struggle to determine appropriate billing paths—especially when post-award amendments or protocol changes arise.

  • Lack of Documentation to Support Coding

    All billed services must be medically necessary and appropriately documented. In clinical trials, this means that study visits and procedures must be clearly supported in the patient’s medical record and must align with both billing claims and the protocol, which outlines the required study activities. Additionally, sites must maintain proper source documentation to support coverage analysis determinations—proving that a service qualifies as routine care is essential for compliant coding and billing. Inadequate documentation can lead to denials, audits, or compliance violations.

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.

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