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Study Type

Documents reviewed

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 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?
  1. The principal purpose is to test if the intervention potentially improves the participant’s health outcome(s).
  2. 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.
  3. The trial does not duplicate existing studies.
  4. The trial design is appropriate to answer research questions being asked in the trial.
  5. The trial is sponsored by a credible organization or individual, who is capable of executing the trial.
  6. The trial is in compliance with Federal Regulations to protect the human subject(s).
  7. 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?