Medicare Coverage Analysis

Determining the eligibility of a clinical study’s related tests, procedures or interventions for Medicare coverage requires a detailed review of the clinical events specified in the protocol to determine which can be reimbursed by Medicare or third party payers. This process, called Medicare Coverage Analysis (MCA), can be cumbersome and time-consuming, yet essential.

Our team of experts offers comprehensive eligibility reviews of your pharmaceutical or medical device clinical trials to determine if they meet the requirements of Medicare’s clinical trial and device policies.  We also work with you to establish comprehensive billing plans for all qualifying studies.

The first step in the analysis process is to determine whether the trial qualifies for coverage. Following a detailed assessment and analysis methodology, we will evaluate your clinical trial protocols, agreements, informed consents and other study documents. This helps you develop and negotiate accurate study budgets with the study sponsor and the patients’ insurance companies.

Working collaboratively with your research team, we help you navigate the complex area of local coverage determination. This is where state Medicare contractors make the majority of coverage decisions, and it can vary from region to region.

National Coverage Determination and Local Coverage Determination (LCD)

While it may seem relatively straightforward if the only Medicare analysis was at the national level, things become even more complicated when considering Local Coverage Determination (LCD). LCDs are written by local or regional fiscal intermediaries representing CMS. This is where many of the pitfalls occur and where many institutions get lost, and also where state Medicare contractors make the vast majority of coverage decisions. A procedure or test may be covered in New York, but not California.

Our team of experts works with LCDs across the country to assist research institutions understand the provisions of these regional Medicare coverage contractors.

Billing Compliance Auditing and Consulting Services

We also offer internal audit services and consultation to ensure your institution is in compliance with regional and federal regulations. We evaluate current protocols and provide on-site compliance reviews.

For more information contact Carmela Houston-Henry at 516-470-6979 or