Following the lead of Medicare and several states, the Affordable Care Act guarantees insurance coverage for individuals participating in clinical trials for the treatment of cancer and other life-threatening diseases.

Under the 2010 health law, health plans offering individual or group coverage cannot bar participation in clinical trials and cannot discriminate against patients who take part in trials. Health plans must cover the routine patient costs associated with participation in certain clinical trials. The plans do not, however, need to cover the investigational drug or device or services provided solely to satisfy data collection and analysis needs.

The policy applies to all phase I-IV clinical trials that are conducted for the prevention, detection, or treatment of cancer or other life-threatening diseases, including federally funded trials, investigational new drug applications reviewed by the Food and Drug Administration, or drug trials that are exempt from having an investigational new drug application.

The new federal policy, which takes effect on Jan. 1, 2014, sets a minimum standard of coverage and permits more expansive state coverage laws to continue.

Dr. Sandra M. Swain, president of the American Society of Clinical Oncology (ASCO), is an expert in the field of inflammatory breast cancer treatment and has led more than 20 clinical trials. She explained how the policy change is likely to impact clinical trial participation.

Question: How many states already mandate coverage of clinical trials and do the laws vary?

Dr. Swain: Twenty-nine states and the District of Columbia have laws and six states have voluntary agreements with insurers to provide coverage. The laws vary tremendously. The laws and agreements do not cover plans for self-insured, large-employer plans (or so-called ERISA plans) because they are regulated by federal, not state law.

Question: Will this new federal policy follow Medicare’s example and covering the treatment of complications in clinical trials?

Dr. Swain: The ACA statute does not specifically mention coverage of complications. ASCO led a coalition of 19 cancer organizations in advocating for the Centers for Medicare and Medicaid Services (CMS) – the federal agency in charge of drafting the implementing regulations – to require in those regulations that insurers cover complications. The coalition submitted proposed regulatory language on this and a number of other issues and met with CMS. We are waiting on the draft regulations.

Question: Is the current lack of insurance coverage for clinical trials a significant barrier to participation?

Dr. Swain: Our members have cited this as a major concern. Health plans do not always deny coverage, but they often don’t make coverage explicit and there is a lot of paperwork and time delays. This can make it difficult for patients to enroll in trials in a timely manner. Some patients also choose not to consider trial participation when they learn that their health plan may not provide coverage. An analysis from Johns Hopkins University, Baltimore, provides the most recent data.

Question: Since this doesn’t apply to grandfathered health plans, how much of an impact is it likely to have?

Dr. Swain: When the Office of Management and Budget released a rule on grandfathered plans in June 2010, it also estimated how many plans would relinquish their grandfathered status by 2013. The conservative estimate is 39% while the high-end estimate is 69%. As time goes on, the number of plans that lose their status will increase, thereby also increasing the effect of the provision.

Question: What will the impact be on cancer research and patients?

Dr. Swain: We’re hoping it will help make it easier to participate in clinical trials. Perhaps our outreach to ASCO members and patients about the provision will increase awareness. Anything that makes it easier to participate in research will ultimately help bring new treatments to our patients.

Question: What will need to be addressed when the Department of Health and Human Services issues regulations on this provision?

Dr. Swain: The statutory language about which trials are covered is very clear. Federally funded trials (including those funded by Cooperative Groups and National Cancer Institute–designated oncology centers) for the prevention, detection, or treatment of cancer are covered – including all phases of trials (I-IV). In addition, these same types of trials that are privately sponsored are covered if they are regulated by the FDA under an investigational new drug (INDA) application or if they meet requirements to be INDA exempt. We are working with the federal government to make the coverage process as timely and straightforward as possible. We developed a standard form that could be sent to any insurer to confirm that a trial meets the coverage requirements. We are hopeful that the federal government will promote use of this type of streamlined process. It is crucial that we help patients obtain a clear coverage answer as quickly as possible.

Dr. Swain is the president of ASCO and the medical director of the Washington Cancer Institute at the MedStar Washington Hospital Center.

Implementing Health Reform: Boosting clinical trial participation