ASCO Urges Administration to Provide Guidance on Protecting Patient Access to Clinical Trials

Alexandria, VA—The American Society of Clinical Oncology (ASCO) joined more than 50 other organizations in urging the Obama administration to issue regulations or guidance before January 2014 to ensure that health plans implement an important provision of the Patient Protection and Affordable Care Act (PPACA) that would remove a critical obstacle to patients interested in participating in research.

In a jointly signed letter to the US Department of Health and Human Services (HHS) and the US Department of Labor (DOL), ASCO lent its voice to a call for clear federal 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 PPACA that goes into effect on January 1, 2014.

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 healthcare providers and impact timely access to potentially life-extending research. According to the cosigned letter, “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.”

“While the administration has made it clear that insurance companies must proceed with compliance, it has left important details unaddressed,” said Clifford A. Hudis, MD, FACP, the president of ASCO. “We know that insured patients with coverage for clinical trial participation have faced denials and delays even in those states that require such coverage, a situation that is unacceptable to patients for whom clinical trials of new therapies may represent their best hope for extension of life or a better quality of life. This also unnecessarily delays the development of better treatments for everyone.”

The letter builds on ASCO’s earlier advocacy efforts with 18 cancer organizations that resulted in submission of recommendations to federal agencies on how to implement the coverage requirement. ASCO is also developing detailed information on the new law for cancer patients, investigators, and research staff, and it will be closely tracking implementation of the law.

Fewer than 5% of patients with cancer and only 6% of patients with severe chronic illness participate in clinical trials. These low participation rates mean that research takes longer, costs more, and ultimately results in delays in the development of new therapies or a lag in evidence about the safety and effectiveness of existing therapies.

Studies have found that patients who are eligible are often denied access to clinical trials. A study published in 2010 found that of 628 eligible patients with cancer denied coverage for their routine clinical trial costs between 2003 and 2008, nearly 80% of those denied had insurance coverage that generally purported to allow coverage for clinical trial participation (Klamerus JF, et al. Clin Cancer Res. 2010;16:5997-6003). In enacting the PPACA provision, Congress sought to remove obstacles to participation in research for patients.

ASCO and the other organizations signing the letter identified 4 key issues that should be addressed through federal rulemaking to ensure that the clinical trials provision of the PPACA is fully implemented:

  • 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 healthcare professional.—Source: American Society of Clinical Oncology, June 19, 2013

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