04 Oct Clinical Trials and The Cost
One of the first questions you or your loved one should consider when thinking about participating in a clinical trial is the cost and whether your medical insurance will cover it. There is not one answer to this question, but let’s look at a big picture.
In most cases, when a patient enrolls in a clinical trial, the study sponsor provides the new treatment at no cost and pays for any tests, procedures, or doctor visits. Some sponsors go even further and pay for things like travel time and mileage. It is important to find out what cost are covered by the study and if you will be stuck with any of the expense. At this point, you also should look at your insurance coverage.
As of January 1, 2014, the Patient Protection and Affordable Care Act required that non-grandfathered health plans (i.e. those that were not in place before March 23, 2010) cannot deny a qualified individual participation in an approved clinical trial, or deny or limit the coverage of “routine costs” in connection with participation in the trial. An “approved clinical trial” is deemed as one that test ways to prevent, detect, or treat cancer and are funded or approved by the federal government and have submitted an FDA Investigational New Drug application (IND) or are exempt from IND requirements. Routine costs” are those that would normally be involved in standard of care, such as doctor visits, blood tests, imaging scans, etc.
State laws may go even further in protecting consumers’ rights to participate in clinical trials. Thirty-seven states and the District of Columbia all have laws on the books regarding clinical trial coverage. For specific information about your state, go to http://TriageCancer.org/statelaws.
Unfortunately, the federal government does not require states to cover clinical trials through state Medicaid plans, so coverage depends on the state in which you live. For specific information about your state, go to http://TriageCancer.org/statelaws.
Like private insurance, Medicare covers routine costs of items and services in covered research studies. Examples of these items and services include room and board at a hospital, the treatment of side effects and complications that may occur as a result of the study, and operations to implant an item that is being tested. For a full understanding of Medicare coverage for clinical trials, go to https://www.medicare.gov/Pubs/pdf/02226.pdf.
TRICARE and Veterans Affairs
Our military members and families also have some coverage for clinical trials. TRICARE will reimburse the medical costs related to taking part in National Cancer Institute (NCI) sponsored trials for cancer prevention and treatment. Veterans Affairs allows eligible veterans to participate in NCI-sponsored clinical trials at VA Medical Centers.
There is good news out there about clinical trial coverage, but you have to your due diligence. Make sure you ask what the study covers and then get a full understanding of what your insurance covers.