ASCO believes that insurance should cover the routine patient costs for people participating in cancer clinical trials. The information below provides resources and highlights ASCO’s policy efforts on the topic.
The federal health care reform law—the Patient Protection and Affordable Care Act (ACA)—includes the requirement that private insurers cover the routine patient costs associated with participation in approved clinical trials. The following resources provide further information about the new requirement and ASCO's ongoing work to inform the community about implementation of the law.
- Information for Providers on ACA Coverage Provision
- Form to Demonstrate that a Trial Meets Statutory Requirements: ASCO has created an attestation form based on the law that can help demonstrate that the trial and patient's circumstances meet the coverage requirements.
- Federal Law
- Summary of Federal Law
- FAQ on Federal Law
- For Your Patients: Fact Sheet for Patients on ACA Coverage (central IRB-approved)
- For Your Patients: Cancer.Net Patient Information Article on ACA Coverage Requirement
Medicare covers the routine patient costs for qualifying clinical trials. The Medicare National Coverage Determination, passed in the year 2000, clarified clinical trials coverage for beneficiaries enrolled in traditional Medicare fee for services (FFS) coverage.
Coverage of Phase 1 Trials
The Medicare policy does not specify the phases of trials that are covered but instead states that a trial “must have therapeutic intent.” It is the position of ASCO and other leading cancer organizations that phase 1 cancer clinical trials have therapeutic intent and therefore should be covered by Medicare. In the past, ASCO has worked with other cancer organizations to provide information to assist research sites with coverage denials related to phase 1 participation. For assistance on this issue, please contact our Research & Analysis team.
Coverage for Medicare Advantage (MA) Plan Participants
A persistent challenge remains for individuals enrolled in Medicare Advantage (MA) or private Medicare managed care plans. The Centers for Medicare and Medicaid Services requires that these beneficiaries revert to FFS coverage if they enroll in a clinical trial. The Medicare Advantage plan is then required to reimburse beneficiaries for the difference in out-of-pocket cost sharing between FFS and their MA plan. ASCO is an opponent of this policy because it serves as a potential financial and bureaucratic disincentive for MA enrollees who want to participate in research.
ASCO Policy Initiatives
- ASCO Policy Statement on the Critical Role of Phase I Trials: ASCO released an updated policy statement in December 2014 calling for greater access to and education about phase I clinical trials. The statement, published in the Journal of Clinical Oncology, stresses the critical importance of phase I clinical trials in cancer research and treatment. The statement emphasizes that this research offers greater potential as a treatment option for many patients than was the case nearly two decades ago, due to molecularly targeted agents and innovative clinical trial designs.
- ASCO collaborated with NCI to update NCI’s protocol template to include language that establishes the therapeutic intent as a secondary objective. The following language is now included in the template (page 8): "[All phase 1 studies must include the following text as a secondary objective.] To observe and record anti-tumor activity. Although the clinical benefit of [this/these] drug(s) has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability." ASCO hopes that inclusion of this objective language will support Medicare coverage of phase 1 trials, considering Medicare’s current policy does not require therapeutic intent to be the primary endpoint of a trial in order for the trial to qualify for coverage.
The state Medicaid programs that have written statutes, regulations, and/or policies that require coverage of the routine care costs associated with clinical trials participation are: Alaska, California, District of Columbia, Indiana, Iowa, Maryland, Montana, North Carolina, Texas, Vermont and West Virginia. Others may have unwritten policies. For more information, please see:
- ASCO Policy Statement on Medicaid Reform
- ASCO Policy Brief on Coverage of Clinical Trials Participation for Medicaid Patients
Thirty-eight states and the District of Columbia have laws or cooperative agreements requiring insurers to cover the routine patient costs associated with clinical trials. The components of the laws vary significantly by state.
|States with Clinical Trials Coverage Laws or Cooperative Agreements|
|1) Alaska||14) Kentucky||27) North Carolina|
|2) Arizona||15) Louisiana||28) Ohio|
|3) California||16) Maine||29) Oregon|
|4) Colorado||17) Maryland||30) Rhode Island|
|5) Connecticut||18) Massachusetts||31) South Carolina (agreement)|
|6) Delaware||19) Michigan (agreement)||32) Tennessee|
|7) District of Columbia||20) Missouri||33) Texas|
|8) Florida (agreement)||21) Montana||34) Vermont|
|9) Georgia (agreement)||22) Nebraska (agreement)||35) Virginia|
|10) Illinois||23) Nevada||36) Washington|
|11) Indiana||24) New Hampshire||37) West Virginia|
|12) Iowa||25) New Jersey (agreement)||38) Wisconsin|
|13) Kansas||26) New Mexico||39) Wyoming|