Clinical trials are scientific investigations that compare the safety and efficacy of new, untested or non-standard treatments. Clinical trials are intended to improve clinicians’ knowledge about a treatment and to improve clinical outcomes for future individuals. Improvement of health outcomes for individuals enrolled in clinical trials is a desirable but secondary consideration.
For Plan years beginning on or after January 1, 2014, the Patient Protection and Affordable Care Act (PPACA) require individual policies and group health plans to cover Routine Patient Care Costs and Services related to an approved clinical trial for a qualified individual.
Coverage is provided for medically indicated and otherwise covered patient care costs associated with qualifying/approved clinical trials as defined below.
Routine patient costs include all items and services consistent with the coverage that is typical for a qualified individual who is not enrolled in a clinical trial. Such items include:
- The services of a physician.
- Diagnostic or laboratory tests.
- Other services provided during the course of treatment for a condition or one of its complications that are consistent with the usual and customary standard of care.
The following requirements must be met:
- The treatment or intervention is provided pursuant to an approved clinical trial that has been federally funded, authorized, or approved by one of the following institutions:
- The National Institutes of Health (NIH) including the National Cancer Institute (NCI);
- The United States Food and Drug Administration (FDA) in the form of an investigational new drug (IND) exemption;
- The United States Department of Defense (DOD);
- The United States Department of Veterans Affairs (VA);
- Centers for Disease Control and Prevention (CDC);
- Agency for Healthcare Research and Quality (AHRQ);
- Centers for Medicare and Medicaid Services (CMS);
- The Department of Energy (DOE);
- A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.
- The proposed therapy must be reviewed and approved by the applicable qualified Institutional Review Board.
- The available clinical or pre-clinical data indicate that the treatment or intervention provided pursuant to the approved cancer clinical trial will be at least as effective as standard therapy, if such therapy exists, and is anticipated to constitute an improvement in effectiveness for treatment, prevention, or palliation of cancer.
- The facility and personnel providing the treatment are capable of doing so by virtue of their experience and training.
- The trial consists of a scientific plan of treatment that includes specific goals, a rationale and background for the plan, criteria for individual selection, specific directions for administering therapy and monitoring individuals, a definition of the quantitative measures for determining treatment response, and methods for documenting and treating adverse reactions. All such trials must have undergone a review for scientific content and validity, as evidenced by approval from one of the federal entities identified above.
The following items and services are not covered care costs:
- The investigational item, device, or service, itself;
- The costs of any non-health service that might be required for a person to receive the treatment or intervention (e.g., transportation, hotel, meals, and other travel expenses),
- The costs of managing the research, or
- Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the individual; or
- The costs which would not be covered under the member’s contractual benefits for non-investigational treatments.
- A service that is clearly inconsistent with the widely accepted and established standards of care for a particular diagnosis.
If a provider is participating in an approved clinical trial, the member may be required to participate in the trial through that participating provider if the provider will accept the member as a participant in the trial.
Treatments that fall outside the designated class of approved clinical trials are not covered. Coverage will not be denied if a member is participating in an approved clinical trial conducted outside of the state in which the member lives.
Any conditions other than those listed as covered will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for this denied service.
An “Approved Clinical Trial” is defined as:
Phase I, Phase II, Phase III, or Phase IV clinical trial, being conducted in relation to the prevention, detection or treatment of cancer or other life threatening disease or condition.
A life-threatening condition is any disease from which the likelihood of death is probable unless the course of the disease is interrupted.
Services provided in conjunction with an approved clinical trial should be reported with a Q0 or Q1 procedure modifier for investigational or clinical services.