Cancer Groups Call for Clarity on Patient Access to Clinical Trials

A group of cancer and other healthcare advocacy organizations applauded a provision in the Affordable Care Act that requires private insurers to cover the routine medical costs of patients participating in clinical trials. However, many of those patients will continue to face roadblocks to participating in trials unless the federal government provides clear guidance on implementation, the groups said in a recent letter.

“A recent HHS and DOL announcement effectively leaves the implementation details of this provision up to the individual states, which is likely to produce a patchwork of uneven and unpredictable coverage that will confuse patients and their health care providers and impact timely access to potentially life-extending research,” said an American Society of Clinical Oncology (ASCO) news release. ASCO and more than 50 other health care advocacy groups signed onto a June 18 letter to the Department of Health and Human Services and the Department of Labor urging federal action before the Patient Protection and Affordable Care Act (PPACA) becomes effective Jan. 1, 2014.

Allowing individual states to guide implementation might lead to delays for many eligible patients in receiving coverage, said Yu-Ning Wong, MD, assistant professor of medical oncology at Fox Chase Cancer Center, in an expert commentary given during ASCO’s recent annual meeting in Chicago. For example, insurance plans that existed on the day the PPACA was signed (March 23, 2010) are exempt from the provision affecting clinical trials coverage until they make changes that reduce benefits or increase costs to consumers, she said.

Several issues need to be addressed through federal rules, considering that clinical trials patients often have trouble getting reimbursed for expenses even when insurers purport to cover those costs, said the co-signed letter. It cited a 2010 study that found that of 628 eligible cancer patients denied coverage for their routine clinical trial costs between 2003 and 2008, nearly 80% of those denied had coverage under their plan.

The letter calls for federal rules in four specific areas:

• Explicit safeguards to ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered under the definition of “routine costs.”

• Regulations to ensure meaningful access to clinical trials and prevent insurers from requiring patients to travel unreasonable distances to enroll in trials with an in-network provider. Since fewer than 4% of all US physicians participate in clinical trials, it is likely that patients will not have meaningful access unless they can use their out-of-network coverage to participate.

• Safeguards to prevent delays and administrative barriers that undermine access to clinical trials.

• Requirements that the determination about whether an individual is an appropriate candidate for a covered clinical trial be made by the patient’s health care professional, since the definition of a life-threatening condition can be subject to various interpretations.