Healthy CT concerning clinical trials
23-June-2014
Certificate of Coverage Terms for HealthyCT policy regarding Clinical Trials
Clinical Trials:
Certain routine care for a Member who is a patient in a disabling or life-threatening chronic
diseases clinical trial, such as for cancer, is covered just as routine care would be covered
under this Plan if the Member were not involved in a disabling or life-threatening chronic
diseases clinical trial. All of the terms and conditions of this document apply.
In order for the Member to be eligible for coverage, the trial must be Prior-Authorized and must
take place under an independent peer-reviewed protocol approved by one of the National
Institutes of Health, by a National Cancer Institute affiliated cooperative group, by the federal
Food and Drug Administration (FDA) as part of an investigational new medication or device
application or exemption, or by the federal Department of Defense or Veterans Affairs.
Coverage includes Hospitalization at a Non-Participating Hospital if the treatment is not
available at a Participating Hospital and is not paid for by the clinical trial sponsor. Payments
made to a Non-Participating Hospital for cancer clinical trials will be made at no greater cost to
the Member than if the treatment were provided at a Participating Hospital.
The State of Connecticut Insurance Department has issued a standardized form that must be
used when a Member asks us to cover routine care costs in a clinical trial.
Denials are subject to the State of Connecticut utilization review external Appeal/Grievance
program.
We may require the following in order for a Member to be considered for coverage:
·
Evidence that the Member meets all of the selection criteria for the trial;
·
Evidence that the Member has given appropriate informed consent to the trial;
·
Copies of any medical records, rules, test results or other clinical information used
to enroll the Member in the trial;
·
A summary of how the expected routine care costs would exceed the costs for
standard treatment;
·
Information about any items or services (including routine care) that may be paid
for by another entity, including the name of the company paying for the trial; and/or
·
Any other information we may reasonably need to review the request.
There is no coverage for the following:
·
Cost of non-Health Services;
·
Cost of Experimental Or Investigational medicines or devices not approved for sale by
the FDA;
·
Costs that are inconsistent with the most accepted and established regional or
national standards of care for a particular diagnosis, or costs for services that are
performed just to meet the requirements of the trial;
·
Costs that would not be covered by this Plan for a non-Experimental or Investigational
treatment;
·
Facility, ancillary, professional services and medicine costs paid for by grants or
funding for the trial;
·
Routine costs that are payable by another entity; and/or
·
Transportation, lodging, food or other travel expenses for the member or any family
member or companion of the Member.
GENERAL CONDITIONS
4. Covered prescription drugs will not be denied as Experimental Or Investigational if the drug
has successfully completed a Phase III clinical trial conducted by the federal Food and Drug
Administration (FDA).
GENERAL EXCLUSIONS (APPLICABLE TO ALL DENTAL SERVICES)
Dental services of a trial, experimental or investigational nature. The determination of a trial,
experimental or investigational is based on the service rendered and not the diagnosis. Please
note
that a dental service is not considered experimental if it has completed a Phase III clinical trial of
the Food and Drug Administration.
EXPERIMENTAL OR INVESTIGATIONAL
A service, supply, device, procedure or medication (collectively called "Treatment") will, in our
sole discretion, be considered Experimental or Investigational if any of the following
conditions are present:
1. The prescribed Treatment is available to you or your Eligible Dependents only through
participation in a program designated as a clinical trial, whether a federal Food and Drug
Administration (FDA) Phase I or Phase II clinical trial, or an FDA Phase III experimental
research clinical trial or a corresponding trial sponsored by the National Cancer Institute, or
another type of clinical trial; or
2. A written informed consent form or protocols for the Treatment disclosing the experimental or
investigational nature of the Treatment being studied has been reviewed and/or has been
approved or is required by the treating facility's Institutional Review Board, or other body serving
a similar function or if federal law requires such review and approval; or
3. The prescribed Treatment is subject to FDA approval and has not received FDA approval for
any diagnosis or condition.
If a Treatment has multiple features and one or more of its essential features are Experimental
Or Investigational based on the above criteria, then the Treatment as a whole will be considered
to be Experimental Or Investigational and not covered.