For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

Agreement: South Carolina Clinical Trials Agreement

Effective: July 1, 2010

What clinical trials are covered?

Phase II, Phase III, or Phase IV clinical trials for cancer if a physician who is providing or is authorized to provide covered healthcare services to the insured under the insured’s health benefit plan contract recommends participation in the cancer clinical trial. The clinical trial must have a meaningful potential to benefit the insured. The trial’s endpoints shall not be defined primarily to test toxicity, but shall have a therapeutic intent. To be covered, the clinical trial must either involve a drug that is exempt under federal regulations from a new drug application or must be a trial that is approved by

• A cooperative group or one of the National Institutes of Health;
• U.S. Food and Drug Administration (FDA), in the form of an investigational new drug application;
• U.S. Department of Defense;
• U.S. Department of Veterans Affairs; or
• National Cancer Institute.

Who is required to pay?

Health insurers, health maintenance organizations, and self-insured governmental employers who have signed the agreement, voluntarily agreeing to provide this coverage. These providers include BlueCross BlueShield South Carolina, BlueChoice Health Plan, Carolina Care Plan, and UnitedHealthcare of the Carolinas.

Other key provisions

• Coverage applies only to trials for which any healthcare providers submitting a claim for payment of services provided as part of the trial have also executed the agreement. Such execution by providers may occur after the original execution of the agreement by the health plans but is required prior to coverage being extended to that trial. The Hollings Cancer Center at the Medical University of South Carolina has executed the agreement as of the effective date (July 1, 2010).
• “Routine patient care costs” are defined as those costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered under the plan or contract if those drugs, items, devices, and services were not provided in connection with an approved cancer clinical trial program. These includes health care services required
  • Solely for the provision of the investigational drug, item, device or service;
  • For clinically appropriate monitoring of the investigational item or service; or
  • For “reasonable and necessary care arising from the provision of the investigational drug, item, device, or service, including the diagnosis or treatment of complications.”
• “Routine patient care costs” excludes the costs of
  • Drugs or devices not approved by the FDA for use associated with the cancer clinical trial;
  • Claims for patients participating in clinical trials that fail to identify all extra services that are not standard medical care;
  • Nonclinical expenses, such as travel, housing, and companion expenses;
  • Items or services provided solely for data collection and analysis purposes and not used in the patient’s clinical management;
  • Health care services that would otherwise be specifically excluded from coverage under the patient’s health plan;
  • Health care services customarily provided free of charge to trial enrollees by the trial sponsors; and
  • The cost of an oncologic drug, if the trial’s purpose is to study the use of the drug in the particular cancer in question or to study the administration of the drug in a new manner.
• Coverage of patient care costs such as additional tests that may or may not be fully covered by the trial sponsor or research institution and other reimbursement issues must be resolved by the trial sponsor and the patient’s health plan. 
• When health care services are provided by a contracting healthcare provider, the payment rate shall be at the agreed-upon rate less applicable insured cost-sharing (e.g., copayments, coinsurance, and/or deductibles). In the case of a non-contracting provider, the payment shall be at the negotiated rate or what the insurer would otherwise pay to a non-participating provider for the same covered services, less applicable out-of-network cost-sharing.
• The agreement does not prohibit, limit, or modify an insured’s rights to any available internal and external review process under South Carolina law (Chapter 71 of Title 38 of the Official Code of South Carolina Annotated, The Health Carrier External Review Act).
• Insurers are not liable for services provided under the terms of this agreement.

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