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Medicare Coverage Analysis (completed by clinical department performing the study)
A Medicare Coverage Analysis (MCA) is necessary for all clinical trials involving interventions in which any items and services are or may be invoiced to the patient insurer(s). The MCA involves determining the underlying eligibility of the study for Medicare coverage and reviewing the clinical events specified in the Protocol (and outlined in the Protocol Billing Grid) to determine which items or services may be billed to Medicare. Medicare’s Clinical Trial Policy only allows coverage of routine costs during qualifying clinical trials.
Medicare will not cover costs that are
paid for by the sponsor,
promised free in the informed consent document,
not ordinarily covered by Medicare,
solely to determine trial eligibility or for data collection or analysis.
Lastly, if this study involves a IDE device, Medicare’s IDE # Policy requires that the local Medicare Contractor determine the coverage of services/items acceptable to invoice to Medicare and a copy of this determination letter should be obtained prior to the release of claims.
If you have questions please contact Joseph Sorrentino at
or call 203-785-7760.
Protocol Number \ IRB Number \ HIC Number
Initial Completion Date (mm/dd/yyyy)
Other Documents Reviewed Please Specify
Medicare Qualifying Criteria (not applicable to device trials)
Does the investigational item or service fall within a Medicare benefit category (e.g., physician services, diagnostic tests)?
Has the item or service been statutorily excluded (e.g., cosmetic surgery, hearing aids)?
Does the trial have a therapeutic intent (i.e., not designed exclusively to test toxicity or disease pathophysiology)?
Do subjects have diagnosed disease (i.e., subjects are not healthy volunteers)?
Is the study deemed? - does the trial fall within at least one of the following categories in the questions that follow.
Meaning the trial is “deemed” to automatically meet the “seven desirable characteristics” of qualifying clinical trials. The local Medicare contractor should be contacted to determine whether items and services will be covered in that geographic area on trials that do not meet the “deemed” criteria.
Is the trial funded by NIH, CDC, AHRQ, CMS, DoD, or the VA?
Is the trial supported by a center or cooperative group that is funded by the NIH, CDC, AHRQ, CMS, DOD, or the VA?
Is the trial conducted under an Investigational New Drug (IND) application reviewed by the FDA?
Is the trial exempt from IND application under 21 CFR 312.2 (b)(1)?
Does the trial meet ALL of the 7 Desirable Characteristics?
The principal purpose is to test if the intervention potentially improves the participant’s health outcome(s).
The trial is well-supported by available scientific and medical information or it is intended to clarify/establish the health outcome(s), of interventions, already in common clinical use.
The trial does not duplicate existing studies.
The trial design is appropriate to answer research questions being asked in the trial.
The trial is sponsored by a credible organization or individual, who is capable of executing the trial.
The trial is in compliance with Federal Regulations to protect the human subject(s).
All aspects of the trial are conducted with appropriate standards of scientific integrity.
Does trial qualify for Medicare coverage?
SOC vs RS Designation in PC Console?
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