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.
Affordable Care Act Requirements for Private Insurance Coverage
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 starting in January 2014. 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
ASCO Policy Initiatives:
Recommendations for Implementing Regulations:
- Development of FAQ for Departments (January 2014) - ASCO worked with the American Association for Cancer Research, American Cancer Society Cancer Action Network, American Heart Association, Association of American Cancer Institutes, and the National Coalition for Cancer Research to develop an additional FAQ document for the Departments to release to help clarify key elements of section 2709. The document addresses the most critical questions related to the implementation of the clinical trials coverage provision. The hope is that in the absence of regulations, this FAQ document will provide guidance to help ensure that the intent of the law is adhered to in a consistent fashion.
- Meeting with CMS on implementation of coverage requirement (April 2012) - ASCO and other leading cancer organizations met with top government regulators to discuss recommendations aimed at ensuring robust implementation of the clinical trials coverage law.
- Comments to CMS on implementation of coverage requirement (January 2012) - ASCO and 14 other leading cancer organizations submitted recommendations to the Centers for Medicare & Medicaid Services to influence development of the clinical trials coverage regulation that will implement section 2709 of the Patient Protection and Affordable Care Act.
Medicare Coverage for Clinical Trial Participants
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 ASCO at ResearchPolicy@asco.org.
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:
- NEW! 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, emphasizing 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.
- NEW! 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.
- Comments to CMS on 2015 MA Coverage (March 2014) - ASCO teamed up with 19 other health organizations to submit comments to CMS urging the agency to change its long-standing policy that requires MA enrollees to revert to FFS coverage while participating in a clinical trial. This year's comment letter also asks CMS to require MA plans and Medicare contractors to inform MA enrollees of the financial assistance available to them for any difference in cost-sharing between FFS and their MA plan they may encounter.
- Comments to CMS on MA Coverage (March 2011) - ASCO and 4 other leading cancer organizations submitted comments to CMS urging the agency to require Medicare Advantage plans to directly cover the routine costs associated with clinical trial participation.
- Comments to CMS on MA Plans Covering the Difference in Cost Sharing (March 2010) - ASCO and AACI submitted comments to CMS commending the agency for choosing to require MA plans to reduce cost sharing for patients participating in clinical trials to the levels each MA plan requires for services similar to those of the trial.
State Laws and Cooperative Agreements
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|