ASCO and Other Cancer Groups Ask for Guidance on Protecting Patient Access to Clinical Trials
A jointly signed letter by ASCO and more than 50 other cancer and health-care organizations to the Secretary of Health and Human Services (HHS) Kathleen Sebelius and Acting Secretary of the Department of Labor (DOL) Seth D. Harris asks that they provide clear federal regulations and guidance on coverage of routine medical costs for individuals participating in approved clinical trials, as required under section 2709 of the Public Health Service Act, a provision of the Patient Protection and Affordable Care Act (ACA) that will go into effect on January 1, 2014.
The letter is in response to an announcement released by HHS and the Department of Labor on April 29, which leaves implementation details of that provision of the ACA up to the individual states, potentially producing uneven coverage that could impact patient access to clinical trials. According to the letter, unless clear direction is given to health insurance carriers before January 1, 2014, “Implementation of this provision will be very uneven across the country and many consumers may be denied a new protection they should be guaranteed under the law.”
Eligible Patients Often Denied Coverage
According to a press release from ASCO, studies have found that patients who are eligible for clinical trials are often denied access to them. The release cited a study published in 2010, which found that of the 628 eligible cancer patients denied coverage for their routine clinical trial costs between 2003 and 2008, nearly 80% had insurance that allowed coverage for clinical trial participation.
With fewer than 5% of cancer patients and only 6% of patients with severe chronic illnesses currently participating in clinical trials, removing any insurance barriers to participation in clinical trials is crucial to improving patient care and furthering research. “Through enhancing our understanding of serious and life-threatening conditions—and of the risks and benefits of promising new therapies—we improve treatment, diagnosis, and prevention options not just for participating patients but for all of us through the advancement of medical knowledge,” wrote the co-signers of the letter.
Guaranteeing Full Access to Clinical Trials
While ASCO and the other health-care organizations applauded Congress for seeking to remove obstacles to participation in clinical trials, they identified four key issues they say should be addressed through federal rulemaking to guarantee full implementation of the ACA. They include:
- Prevention, Detection, and Treatment of Complications. Explicit safeguards should ensure that the prevention, detection, and treatment of complications arising from clinical trials are covered under the definition of “routine costs.”
- Meaningful Access to Clinical Trials. Regulations should prevent group health plans and insurance issuers from requiring patients to travel unreasonable distances to enroll in a clinical trial with an in-network provider.
- Prevention of Delays and Administrative Barriers. Safeguards should protect patients from delays and administrative barriers that undermine access to clinical trials, including preventing financial incentives arising from new delivery models from inadvertently creating barriers for patients to participate in clinical trials.
- Determining a Life-threatening Condition. Determination about whether an individual is an appropriate candidate for participation in a trial that qualifies for coverage should be made by the patient’s health-care professional.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
