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Let ASH Know About Difficulties in Obtaining Guaranteed Coverage for Clinical Trials

Guaranteeing access to clinical trials for cancer patients has long been a priority for ASH, and with the united efforts of many other organizations, significant strides have been made in improving access. Under the terms of an ASH-supported provision contained in the health reform law that became effective January 1, 2014, insurers are prohibited from dropping coverage because an individual chooses to participate in a clinical trial and from denying coverage for routine care that they would otherwise provide just because an individual is enrolled in a clinical trial.

ASH previously joined several organizations in submitting recommendations in advance of anticipated rulemaking to implement the clinical trials coverage provision. However, before the provision went into effect, the Departments of Health and Human Services and Labor (which are both responsible for implementing the various provisions of the health reform law) announced there would not be federal regulations to implement the clinical trials coverage provision of the health reform law. The agencies determined the statutory language was self-implementing, and indicated that the Departments do not expect to issue regulations in the near future. Rather, the Departments determined that, “group health plans and health insurance issuers are expected to implement the requirements . . . using a good faith, reasonable interpretation of the law.”

Since that decision, ASH has repeatedly joined many organizations in expressing concern that, absent federal regulations, “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.”

ASH is continuing to work with physician organizations and patient groups to ensure adequate coverage for those enrolled in clinical trials and we need to hear from you about any difficulties you or your patients have encountered in obtaining coverage for clinical trials. Specifically, please let us know: 

  1. Examples of why plans are denying coverage clinical trials;
  2. The approximate length of time it takes to resolve appeals for denial of coverage of clinical trials;
  3. The approximate percentage of appeals cases resolved, and the approximate percentage of patients either approved or denied coverage in the final determination of the appeal; and
  4. Any additional information that you believe would be helpful with regard to denials of clinical trials coverage.

Please forward any information or questions you may have on this issue to ASH Legislative Advocacy Manager Tracy Roades.