Insurance coverage Coverage for Clinical Trial Participants |

ASCO believes that insurance ought to cover the routine patient expenses for folks participating in cancer clinical trials. The details below offers resources and highlights ASCO’s policy efforts on the topic.

ACA Specifications for Personal Insurance Coverage | Medicare Coverage | State Laws and Cooperative Agreements

Affordable Care Act Specifications for Private Insurance Coverage

The federal health care reform law—the Patient Protection and Inexpensive Care Act (ACA)—includes the requirement that private insurers cover the regimen patient costs connected with participation in accepted clinical trials beginning in January 2014. The following assets supply additional data about the new necessity and ASCO’;s ongoing function to inform the local community about implementation of the law.


ASCO Policy Initiatives:

Recommendations for Implementing Regulations:

  • Development of FAQ for Departments (January 2014) – ASCO worked with the American Association for Cancer Analysis, American Cancer Society Cancer Action Ne2rk, American Heart Association, Association of American Cancer Institutes, and the National Coalition for Cancer Analysis to develop an added FAQ document for the Departments to release to help clarify crucial factors of segment 2709. The document addresses the most essential questions associated to the implementation of the clinical trials coverage provision. The hope is that in the absence of regulations, this FAQ document will supply guidance to aid make certain that the intent of the law is adhered to in a consistent vogue.
  • Meeting with CMS on implementation of coverage requirement (April 2012) – ASCO and other top cancer organizations met with top government regulators to talk about suggestions aimed at guaranteeing robust implementation of the clinical trials coverage law. 
  • Comments to CMS on implementation of coverage requirement (January 2012) – ASCO and 14 other major cancer organizations submitted suggestions to the Centers for Medicare & Medicaid Providers to influence advancement of the clinical trials coverage regulation that will implement part 2709 of the Patient Protection and Cost-effective Care Act.

Medicare Coverage for Clinical Trial Participants

Medicare covers the routine patient fees for qualifying clinical trials. The Medicare Nationwide Coverage Determination, passed in the 12 months 2000, clarified clinical trials coverage for beneficiaries enrolled in traditional Medicare charge for companies (FFS) coverage.

Coverage of Phase 1 Trials:

The Medicare policy does not specify the phases of trials that are covered but alternatively states that a trial “must have therapeutic intent.” It is the place of ASCO and other foremost cancer organizations that phase 1 cancer clinical trials have therapeutic intent and as a result should be covered by Medicare. In the previous, ASCO has worked with other cancer organizations to give information to assist research websites with coverage denials related to phase 1 participation. For support on this concern, please make contact with ASCO at

Coverage for Medicare Benefit (MA) Strategy Participants:

A persistent challenge remains for people enrolled in Medicare Advantage (MA) or personal Medicare managed care plans. The Centers for Medicare and Medicaid Solutions requires that these beneficiaries revert to FFS coverage if they enroll in a clinical trial. The Medicare Benefit strategy is then necessary to reimburse beneficiaries for the big difference in out-of-pocket price sharing in between FFS and their MA prepare. ASCO is an opponent of this policy simply because it serves as a potential economic and bureaucratic disincentive for MA enrollees who want to participate in investigation.   


ASCO Policy Initiatives:

  • NEW! Comments to CMS on 2015 MA Coverage (March 2014) – ASCO teamed up with 19 other overall health organizations to submit remarks to CMS urging the agency to change its long-standing policy that needs MA enrollees to revert to FFS coverage although participating in a clinical trial. This year’;s comment letter also asks CMS to require MA programs and Medicare contractors to inform MA enrollees of the monetary help available to them for any distinction in cost-sharing amongst FFS and their MA strategy they may experience. 
  • Comments to CMS on MA Coverage (March 2011) – ASCO and 4 other top cancer organizations submitted remarks to CMS urging the agency to demand Medicare Benefit plans to directly cover the schedule costs linked with clinical trial participation.

State Laws and Cooperative Agreements

Thirty-6 states and the District of Columbia have laws or cooperative agreements requiring insurers to cover the routine patient expenses linked with clinical trials. The components of the laws fluctuate substantially by state.


Leave a Reply

Your email address will not be published. Required fields are marked *