Now that Congress and the Obama Administration have set their sights on accelerating the pace of cures in the U.S., it’s a good time to take stock of both the progress and challenges in bringing improved treatments to the more than 1.6 million Americans who will be diagnosed with cancer this year.

On the plus side, progress against cancer is occurring at breakneck speed. In 2015 alone, the Food and Drug Administration approved 14 novel cancer medicines, including ten immunotherapies that free up the body’s immune system to recognize and destroy specific cancer cells. Additionally, scientific discoveries are changing cancer care from a one-size-fits-all approach to precision therapy where the genetic and molecular profile of the patient’s cancer determines the best treatment strategy.

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At the heart of these treatment advances are cancer clinical trials that find the answers necessary to develop innovative medicines. In fact, without these studies, there would be no better tests, treatments and possible cures for cancer and other diseases. Yet, too often, researchers have difficulty enrolling Americans in clinical trials. This is especially the case in cancer where today, only 2-5 percent of adult patients participate in these studies.

Why? One reason is widespread misperceptions among the public about clinical trials, such as the myths that some individuals get a placebo instead of the best treatment or must travel long distances to take part in a study. Many also believe that clinical trials only make sense when patients have a terminal cancer or don’t have other treatment options when in reality, clinical trials are offered for all stages of cancer, including for newly diagnosed patients.

Because these myths are pervasive, education about clinical trials is essential and the cancer community is responding with a number of awareness initiatives. This includes the Clinical Trials Resource Guide, a new online module from Project Innovation – a national campaign spearheaded by the National Patient Advocate Foundation to put cancer innovation on the public’s radar – that explains the value of clinical studies from the patient perspective. Our message is simple: cancer clinical trials are at the heart of delivering breakthrough medicines to patients and saving lives.  

Stepped up education, however, is only part of the solution to greater clinical trial participation. Equally important is ensuring that health plans cover the routine medical costs when patients are enrolled in clinical studies. These are not the cost of procedures, drugs, extra doctor visits and expenses directly related to the study itself, which are usually covered by the trial sponsors. What is at issue are the charges insurance normally covers, such as such as physician fees, hospital charges, and routine tests.

However, while many insurers offer coverage for clinical trials, some health plans deny reimbursement due to liability concerns while others limit coverage to the extent that patients wanting to enroll in a trial cannot do so. In these situations, patients are left with the difficult choice of having to pay the out of pocket costs or forgoing the trial altogether. To remedy the problem, Section 2709 of the Affordable Care Act mandated that group health plans and insurance issuers cover the regular medical costs when patients are in a clinical study. Yet, the original language lacked the specificity payers and providers needed.

It took a number of years for the Obama Administration to expressly define what insurers must cover.   However, on April 20, the Departments of Labor, Health and Human Services, and the Treasury jointly issued a clarification document to answer persistent questions about ACA provisions, including what expenses are considered the “routine patient costs” associated with clinical trials. As spelled out by the Obama Administration, these costs encompass “all items and services consistent with the coverage provided in the plan that are typically covered for a qualified individual who is not enrolled in a clinical trial.” Moreover, the Administration specifies what expenses are not covered, such as the drug or device under study, services directly related to the study itself, and those not used in the direct clinical management of the patient.

Now that insurers have detailed information on coverage requirements, it is time for those health plans that have yet to cover clinical trial costs to do so. Patients need greater access to, and reimbursement for, breakthrough treatments available through clinical trials and the clarification document puts to rest any lingering questions. As a stakeholder engaged in the effort to improve access to clinical trials, we will continue to work with policymakers, providers, the advocacy community, patients and caregivers to build education and access to clinical trials.


Balch is Chief Executive Officer, National Patient Advocate Foundation