A coverage analysis is a systematic, document-based review of a clinical trial protocol that determines which items, services, and procedures can be billed to Medicare or other third-party payers, and which must be paid by the study sponsor. The analysis interprets the protocol against national and local coverage rules and produces a billing plan that distinguishes routine, reimbursable care from research-related costs. A thorough coverage analysis protects sites from billing errors and the risk of non-compliant or duplicate claims.
Coverage Analysis
“It’s the collaboration with our clients that enables our experts to create the most thorough coverage analysis.”
Alex MorilloSenior Director, Coverage Analysis and Budgets
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Figuring out what procedures can be reimbursed by Medicare or third parties is complicated. Our experts interpret study protocols and clearly communicate the coverage analysis findings so clients understand billing requirements.
Expert Analysts
Our team provides detailed coverage analyses for clinical trials in all therapeutic areas including oncology and medical devices. They understand study protocol review, standard of care practices, insurance programs, National Coverage Determinations (NCD), and the complexities of Local Coverage Determinations (LCD).
Complete Billing Plans and Grids
The billing plans we create based on our coverage analysis include applicable NCDs, related national guidelines, and journal references to distinguish between routine procedures covered by insurance and sponsor-covered procedures. We also review and include applicable LCDs, which can uncover potential limitations such as understanding which procedures or tests covered in one state may not be covered in another.
Collaborative & Educational Experience
Our Coverage Analysis team members can collaborate with your staff to provide a beneficial educational experience as they work together. They can pass along their knowledge of coverage analysis best practices and how to use strategies like standardized processes and checklists to increase accuracy and efficiency.
Flexible Approach
Over the years, we’ve developed and honed our strategies and processes, but we understand that institutions have their own needs and preferences. We are able and willing to adapt our approach to ensure a positive and efficient working relationship.
Frequently Asked Questions
Does coverage analysis include Medicare coverage analysis?
Yes. A Medicare coverage analysis (MCA) is a core component of a complete coverage analysis. While a coverage analysis reviews how all protocol-required items and services should be billed across every payer, the Medicare coverage analysis specifically determines whether a study is a "qualifying clinical trial" under the CMS Clinical Trial Policy and which routine costs Medicare will reimburse under National Coverage Determination (NCD) 310.1. Because Medicare rules often set the standard that commercial payers follow, the Medicare coverage analysis typically anchors the broader analysis and the resulting billing plan.
Why is coverage analysis important for clinical trials?
Coverage analysis for clinical trials is the foundation of compliant research billing. Without it, sites risk billing Medicare for items the sponsor is obligated to pay, billing twice for the same service, or missing reimbursement they are entitled to, each of which carries financial and regulatory exposure. A well-built coverage analysis also gives research institutions leverage in sponsor budget negotiations by clearly documenting which costs the study, rather than insurance, should cover.
How do I know if a clinical trial qualifies for Medicare coverage?
Under NCD 310.1, a trial must meet three core requirements to qualify for Medicare coverage of routine costs: the subject of the trial must evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded; the trial must have therapeutic intent and not be designed solely to test toxicity or disease pathophysiology; and trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Confirming qualifying status is the first step of any Medicare coverage analysis, and BRANY provides qualifying clinical trial screening as part of its service.
What is the difference between routine costs and research costs in a coverage analysis?
Routine costs are the items and services that would be provided as part of a patient's standard care even if they were not enrolled in the trial. These are generally billable to Medicare or insurance in a qualifying clinical trial. Research costs, by contrast, include the investigational item or service itself and any procedures performed solely to satisfy data collection or analysis needs; these are typically the sponsor's responsibility and are not billed to payers. Correctly separating the two is the central task of a coverage analysis.
What is a billing grid (or billing plan)?
A billing grid maps every protocol-defined procedure and visit to a billing designation (routine/billable to insurance, sponsor-paid, or research-only) supported by applicable NCDs, national guidelines, and journal references. It gives the research and billing teams a single source of truth for how each charge should be handled.
What is the difference between an NCD and an LCD in coverage analysis?
A National Coverage Determination (NCD) is a nationwide Medicare policy that applies uniformly across all states, while a Local Coverage Determination (LCD) is issued by a regional Medicare Administrative Contractor and can vary from state to state. Both matter in a coverage analysis: a procedure covered in one state under an LCD may not be covered in another. BRANY's billing plans incorporate applicable NCDs, related national guidelines, journal references, and the relevant LCDs to capture these regional limitations.
Who should perform a coverage analysis?
Coverage analysis requires expertise in protocol interpretation, standard-of-care practices, Medicare coverage rules (NCDs and LCDs), and research billing compliance. Many institutions use experienced analysts, whether in-house or through a specialized partner, to ensure accuracy across therapeutic areas such as oncology and medical devices.
How does BRANY perform a coverage analysis for clinical trials?
BRANY's analysts interpret the study protocol, screen for qualifying clinical trial status, and build a complete billing plan and billing grid that assigns each protocol-required procedure to the correct payer. Our coverage analyses span all therapeutic areas, including oncology and medical devices, and incorporate applicable National and Local Coverage Determinations, national guidelines, and supporting references. We also ensure document congruence across the protocol, informed consent, and budget, and can collaborate with your staff to share coverage analysis best practices.