Does Medicare Cover a Clinical Trial? 

For most seniors undergoing any type of medical treatment, care is standardized using tested and studied medications and therapies. In order to develop new medications and therapies, however, the process of development usually involves clinical trials.

Clinical trials are studies that test novel treatments and are required by the United States Food and Drug Administration (FDA) in order for a medication or treatment to gain approval for use on the general population. These treatments have some form of evidence to back up their potential for positive outcomes, but they have yet to be proven as safe and effective. The point of clinical trials is to see the effects new treatments have on humans with specific medical conditions.

Who Qualifies for Clinical Trials?

Clinical trials are not open to everyone. In order to be considered for a clinical trial, you must meet certain criteria set out by the conductors or sponsors of the trial. Additionally, there are four different phases of clinical testing. Someone who is involved in one phase may not be involved in another.

The following is a breakdown of the basics of each phase:

Phase One Clinical Trial

Phase one of a clinical trial is usually conducted on a small group of people to monitor for side effects and check dosing before testing begins on a larger group of participants.

Phase Two Clinical Trial

In phase two of a clinical trial, drugs and treatments are administered to a larger group of people to study the initial effectiveness of a therapy.

Phase Three Clinical Trial

Phase three of a clinical trial involves an even larger group of participants and includes the same testing and studies of the first two phases, but different doses may be tried to study the change in effects. This is also the phase where a drug or treatment can receive FDA approval.

Phase Four Clinical Trial

Lastly, phase-four clinical trials take place after a treatment receives FDA approval. This phase is where the effects of a treatment on a large population are studied after a drug has been widely adopted.

Does Medicare Cover a Clinical Trial?

In general, clinical trials do not cost anything to participate in. In fact, some clinical trials may provide forms of compensation to participants. If costs to the participant are involved and that participant is a Medicare recipient, Medicare insurance may cover costs. 

In order for clinical trial costs to be considered for Medicare coverage, however, the services rendered during the clinical trial must fall under the same coverage regulations of traditional Medicare benefits. This means that the services rendered must be provided to treat a covered medical condition that Medicare would normally cover.

Automatic Qualifications for Coverage

Medicare benefits automatically cover clinical trials that are funded by:

• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention (CDC)
• Agency for Healthcare Research and Quality (AHRQ)
• Department of Defense (DOD)
• Centers for Medicare & Medicaid Services (CMS)
• Veterans Affairs (VA)

Investigational new drug (IND) application trials are also automatically covered by Medicare benefits. Trials that are exempt from an IND are also covered. What’s important to note here is that Medicare benefits do not apply retroactively. If the status of a clinical trial changes from excluded to covered, the costs incurred during the exclusionary period will not receive backdated coverage.

What Medicare Covers in a Clinical Trial

In terms of Medicare coverage for services and treatment during a clinical trial, Medicare recipients can expect to receive full coverage for conventional care items, investigational study medications, services and care required as a result of the use of a study medication or treatment.

As for travel to and from a testing site or clinical evaluation facility, sponsors of the trial may offer reimbursement depending on how the study is set up. In general, Medicare benefits do not cover travel expenses to things like doctor visits, but in the case of a clinical trial, reasonable expenses to take part in the trial may be covered.