A common patient misperception is that insurance companies do not cover medical care for those enrolled in trials.   In an effort to decrease barriers to clinical trials and encourage research, President Clinton issued an executive memorandum on June 7th 2000 extending medicare coverage to include routine medical care and complications while on trials.  Details of medicare coverage of clinical trials may be found at http://www.cms.hhs.gov/coverage/8d.asp#decision.

Medicare defined routine costs associated with clinical trials include:

• Services that are typically provided absent a clinical trial (e.g., conventional care, routine blood work, physician visits, hospital stays).
• Items or services required solely for the provision of the investigational item or service.  The investigational drug itself is not covered by medicare, but the administrative costs (infusion fee) and physician evaluation and management fees are covered. (Medicare modifier QV to be used with CPT code)
• The clinically appropriate monitoring of the effects of the item or service, or the prevention of complications.
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service—in particular, for the diagnosis or treatment of complications (supportive care such as anti-nausea medications and growth factors).
• Administration of non compendia listed (off label) FDA approved chemotherapeutics on trial as defined by the FDA Final Coverage Decision found at http://www.cms.hhs.gov/coverage/8d2.asp. and http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=90#appendixa listing the selected Phase I-III trials.  

Insurance co-pays and deductibles for routine patient care while on trials will continue to be collected from the patient according to their insurance plan.  Compendia listed chemotherapy treatments for appropriate diagnosis while on a clinical trial will continue to be billed to insurers, just as standard chemotherapy treatments would be covered. 

Medicare defined items which are not covered on trial include:

• Items and services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient (ie, monthly CT scans, pharmacokinetic blood draws, research nurse salary)
• Items and services which are provided free by the trial sponsor

Tests required for the research protocol beyond routine medical care, such as extra scans, additional blood work, procedures, or labs are to be provided by the trial sponsor.  The experimental drug is to be provided by the sponsor.   However, appropriate supportive medications, medical monitoring, procedures (including administrative and infusion fees) for routine care are to be covered by insurers. 

Twenty-two states have passed legislation supporting private insurance health plans to cover routine medical care while on trials.  An updated list of states with this legislation may be found at http://www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs.   In January 2002, North Carolina passed Senate Bill #199 mandated that all health insurance plans cover routine costs associated with clinical trials using Investigational New Drugs (IND) approved by the FDA.  The trial must be conducted by a “facility and personnel that maintains a high level of expertise because of their training, experience and volume.”    The law may be found at http://www.ncga.state.nc.us/Sessions/2001/Bills/Senate/HTML/S781v1.html.   The NC law also mandated that patients suffering from a life threatening illness (such as metastatic cancer) may designate a specialist capable of coordinating their care a primary physician.    More recently, a 2005 NC legislative amendment requires all clinical trial results to be published accessible to the public at a centralized federal trial registry database. 

The largest study conducted to address the cost of a clinical trial versus standard of care was published in the June 2003 Journal of American Medical Association and reported that trials are only slightly more expensive than standard of care.   With 1,500 patients studied, the average trial patient’s cancer care costs were $35,000 compared to $33,000 standard of care costs for non-participants.