American Society of Hematology

ASH Joins in Urging Federal Agencies to Issue Regulations to Implement Clinical Trials Coverage Provision of Health Reform Law

Published on: June 20, 2013

ASH joined more than 50 organizations in sending a letter to the Secretaries of Health and Human Services and Labor, urging the agencies to issue regulations or guidance implementing an ASH-supported provision contained in the Affordable Care Act that prohibits insurers 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.

Under the terms of an ASH-supported provision contained in the health reform law that becomes effective January 1, 2014, insurers will be 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.

In late April, 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.”

The June 18 letter sent by ASH and the other organizations expresses 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.” The letter urges the Departments to either issue regulations or guidance prior to the January 1, 2014 effective date of the provision or “conduct immediate outreach to states operating exchanges to ensure that clinical trials coverage is included and establish a clear and effective mechanism for consumers to report concerns relating to the coverage of clinical trials.”

ASH will continue to work with physician organizations and patient groups to ensure adequate coverage for those enrolled in clinical trials.

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