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Clinical Trials

Provider Administrative Policy

Care Management
Policy Date
August 2005
Revised/October 2011


Our provider administrative policies contain information regarding claims submission, reimbursement, and other information in order to achieve an efficient relationship with our providers. These policies are not an authorization or explanation of benefits. Blue Cross of Idaho retains the right to add to, delete from and otherwise modify this policy in accordance with our provider contracts.


Clinical Trials

Blue Cross of Idaho Medicare Advantage Plans members receive the same coverage for clinical trials as a person in an Original Medicare plan. Important factors providers need to understand include:


  • The clinical trial must be a qualifying Medicare clinical trial.
  • No prior authorization is required; members are encouraged to notify Blue Cross of Idaho in order to keep track of health care services.


  • Medicare carriers and intermediaries will pay providers for clinical trial services furnished to Blue Cross of Idaho Medicare Advantage members.
  • For claims with a Medicare Summary Notice (MSN)/EOB, Blue Cross of Idaho pays the member the difference between Original Medicare cost-sharing for qualified clinical trial items and services. This cost-sharing reduction requirement applies to all qualifying clinical trials. We are not able to choose the clinical trials or items and services to which this policy applies. Blue Cross of Idaho owes this difference even if the member has yet to pay the clinical trial provider. Additionally, we must include the member's in-network cost-sharing portion in their out-of-pocket maximum calculation. We require claims for services related to a clinical trial to include modifier Q0 or Q1 for each HCPCS code related to the trial.
  • If we receive a claim with lines containing modifier Q0 or Q1 but no accompanying Medicare Summary Notice/EOB, Blue Cross of Idaho will process the claim indicating member responsibility for the Original Medicare cost-sharing and include a remark that the member must submit the Medicare Summary Notice/EOB for correct cost-sharing reductions.

Routine covered costs of clinical trials-defined by Medicare:

  • Included are items or services typically identified as covered medical services according to the member's BSBS and or the member's EOC. For coverage consideration services must fall into the Medicare covered benefit category.

Non-covered costs of clinical trials according to Medicare:

  • Routine costs of qualified clinical trials do not include the cost of investigational items of service, items and services for which there is no Medicare benefit, statutorily excluded items, or that fall under a national no coverage policy. These items and services are the member's responsibility unless otherwise arranged.


  • government and private studies across the country, a service of the National Library of Medicine.
  • (800) 422-6237-Cancer Information Services, provides cancer information and help in locating cancer trials, a service of the National Cancer Institute.
  • This site list trials for patients with cancer and detailed information about cancer trials. This site is a service of the National Cancer Institute.

Policy History

Date Action Reason
October 2011 Revised Language revision
May 2008 Revised Last paragraph added

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