What is a coverage analysis in research?
Coverage analysis is a review to determine if a research study is eligible to receive Medicare coverage and outlines what items and services performed as part of the research study should be billed to Medicare. When coverage analysis is overlooked, hospitals and research sites are subject to audits and lawsuits.
What is MCA in research?
A Medicare Coverage Analysis (MCA) is required for research studies which may bill protocol required routine care services to patients or third-party payors (medical insurance companies).
What is a coverage analysis clinical trial?
Coverage Analysis is an independent review of a human research study to determine which clinical procedures and services are billable to insurance and which are not.It is a systematic review of clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage …
What is an MCA in clinical trials?
A Medicare coverage analysis (MCA) is required for all clinical trials in which tests, procedures, and interventions associated with a clinical trial are invoiced to third party payers.
Which documents should be harmonized with the coverage analysis?
The Informed Consent Form (ICF) cost language must be easily understood and harmonized with the coverage analysis and contract because: A patient should clearly understand which services are being paid by the sponsor and for which they are financially responsible.
What part of research shows the coverage of the research?
The scope of a study explains the extent to which the research area will be explored in the work and specifies the parameters within which the study will be operating.
What is an IIS study?
Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups.
What is a sponsor in research?
A person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
Why is coverage important in research?
What is a Coverage Analysis and Why are they Important for Research Programs? A coverage analysis is an evaluation of a clinical research study that is done in order to determine if the study sponsor or the patient/insurance will pay for each item or service required by the study.
What are routine costs as defined by Medicare?
Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of …