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Clinical Trial Cost Considerations
Medicare
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Medicare pays for routine patient care costs associated with certain clinical trials. According to the Health Care Finance Administration, clinical trials automatically qualify if they are conducted under an investigational new drug application (IND) reviewed by the FDA, or if the trials are supported or funded by:
- The National Institutes of Health
- The Centers for Disease Control
- The Health Care Finance Administration
- The Department of Defense
- The Veterans Administration
- The Agency for Healthcare Research and Quality
If a trial is not supported by any of the agencies listed above, it must meet the following criteria to qualify for Medicare coverage:
- The purpose of the trial must be the evaluation of a service or item that falls under general Medicare coverage (such as physicians services, durable medical equipment, diagnostic testing). Medicare will not cover trials studying procedures or items that are not generally paid for by Medicare (such as cosmetic surgery, hearing aids).
- The purpose of a trial must have therapeutic treatment intent or study the effectiveness of diagnostic procedures.
- Healthy volunteers may only participate in diagnostic intervention trials (as control groups).
- Eligibility for treatment studies requires that participants be diagnosed with a related medical condition.
- The principal purpose of the trial is to test whether the treatment potentially improves the participants' health outcomes.
- The trial is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of treatments already in common clinical use.
- The trial doesn't unjustifiably duplicate existing studies.
- The trial design is appropriate to answer the research question being asked in the trial.
- A credible organization or individual capable of successfully executing the trial sponsors the trial.
- The trial is in compliance with Federal regulations relating to the protection of human subjects.
- All aspects of the trial are conducted according to the appropriate standards of scientific integrity.
Medicare does cover the following routine costs associated with those clinical trials that meet with Medicare's criteria:
- All items or services that are typically covered for the standard treatment of a condition (in other words, treatment that would be provided if there were no clinical trial).
- Items or services required solely for the purpose of the study (such as the cost of administering an unapproved chemotherapy drug), and the associated costs of tests monitoring the effects, or the prevention of complications.
- Items or services needed for reasonable and necessary care arising from complications, as a result of the treatment being studied - in particular, for the diagnosis or treatment of the complication.
Medicare does not cover the following costs associated with clinical trials:
- The cost of the treatment or drug being studied (this cost is generally covered by the trial sponsor).
- Tests or other services designed solely to satisfy data collection and analysis for the trial, and are not used for direct management or treatment of the participant's condition (such as monthly CT scans for a condition usually requiring only a single scan).
- The costs for services or items that are customarily provided free of charge by the trial sponsor.
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