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Policy Compendium

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INS-028: National Cancer Institute Clinical Trials

 
National Cancer Institute Clinical Trials: The Wisconsin Medical Society recommends that the Centers for Medicare and Medicaid Services (CMS) and other third-party payers not deny coverage and reimbursement for the costs of medical care to patients entered in qualifying clinical trials of therapeutic regimes at any phase. Covered costs should include routine health care costs and those usually covered (hospital care and physician and other health care services), as well as the costs of all FDA-approved agents utilized in the trial, regardless of whether the use is for an on-label or off-label indication. Qualifying clinical trials must satisfy all of the following inclusion criteria:

  • Treatment is provided with a therapeutic intent (intent refers to an intention to improve patient outcome, relative to survival or quality of life).
  • Treatment is being provided pursuant to a clinical trial that has been approved by the appropriate institute of the National Institutes of Health (NIH) as identified in the guidelines for NIH grants.
  • The proposed therapy has been reviewed and approved by a qualified institutional review board.
  • The facility and personnel providing the treatment are capable of doing so by virtue of their experience and training.
  • There is not noninvestigational therapy that is clearly superior to the protocol treatment.
  • The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as noninvestigational therapy.
  • That CMS and other third-party payers cover costs associated with clinical trials for patients with malignancy or premalignant conditions as conducted by NIH-approved National Cancer Institute. (HOD, 0416)