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

Aug 22, 2013

ASCO joined more than 50 organizations in urging the Obama administration to issue regulations or guidance before January 2014 to ensure health plans implement an important provision of the Affordable Care Act (ACA) that would remove a critical obstacle to patients interested in participating in research.

In a jointly signed letter to the U.S. Department of Health and Human Services (HHS) and Department of Labor (DOL), ASCO lends 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 Patient Protection and ACA 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 states, which is likely to produce a patchwork of uneven coverage that will confuse patients and their health care providers, and impact timely access to potentially life-extending research.

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

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