A coverage analysis is often referred to as Medicare Coverage Analysis (MCA). The MCA is based on National Coverage Determination (NCD) 310.1 which outlines how a clinical trial qualifies for coverage as per CMS. The MCA is a systematic approach to assess which study-related clinical items, services, and procedures are eligible to be billed to Medicare or other third-party payers and which must be paid by the study sponsor as it relates to the protocol-indicated patient population. The analysis interprets the protocol against national and local coverage policies and guidelines and produces a billing plan that outlines routine care clinical items versus research-related costs. A thorough coverage analysis helps ensure accurate billing and compliance with Medicare regulations while tracking clinical services. It protects institutions 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
Why is coverage analysis important for clinical trials?
Coverage analysis for clinical trials is the foundation of compliant research billing and may serve as the building block for clinical trial budgets and a guide for internal audits. The MCA involves a thorough review of the study protocol to ensure that all study-related clinical procedures are correctly identified and classified with appropriate CPT codes and billed to the appropriate party. The MCA helps verify completeness, consistency with the protocol and compliance with Medicare policies to prevent potential billing errors and ensure proper study budget reimbursement. 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 may lead to financial and regulatory exposure and/or penalties. A well-developed coverage analysis gives research institutions leverage in budget negotiations with sponsors by clearly documenting which costs the study should cover as opposed to insurance.
How do I know if a clinical trial qualifies for Medicare coverage?
Under NCD 310.1, also known as CMS Clinical Trials Policy, 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.
In addition to the above core requirements, the clinical trial must meet one of the following:
- Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
- Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA;
- Trials conducted under an IND reviewed by the FDA; and
- Drug trials that are exempt from having an IND.
Confirming qualifying status is the first step of the Medicare coverage analysis. 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 routine 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, may 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 identifying and separating the two is the central task of a coverage analysis for the purpose of ensuring routine care designations are applied both consistently and appropriately, aligning with Medicare’s policies.
What is a billing grid (or billing plan)?
A billing grid is a schedule of assessments that outlines every protocol-defined and hidden procedures and visits by adding billing designations to study assessments with routine care billable to insurance, sponsor-paid/r research-only or non-billable, which includes citations of applicable NCDs, LCDs, 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 grids 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 nuances of a study protocol, screen for qualifying clinical trial status, and design a billing grid with unhidden and hidden assessments and visits for complete transparency. BRANY billing grids assign each protocol-required clinical procedure (both hidden and unhidden) to the correct payer with color coding for easy identification. 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 perform a quality check to ensure document congruence across the protocol, informed consent, and budget, and can collaborate with your staff to share coverage analysis best practices.