The Connecticut state legislation regarding clinical trials includes information on hospitalization at out-of-network facilities, HMO and insurer requirements, and accountability of private insurers.
Public Acts 11-172, 07-75 and 07-67
“These laws discuss health insurance coverage for routine patient care costs associated with certain clinical trial patients, coverage of hospitalization treatment at an out-of-network facility for patient in cancer clinical trials, and the definition of medical necessity and external appeal provisions.”
The Managed Care Accountability Act 99-284
Signed into law: July 7, 1999, Effective date: 1/1/00.
- Each individual health insurance policy delivered, issued, renewed, amended or continued on or after 1/1/00 must define the extent to which it provides coverage for experimental procedures
- Expedited appeals for denials of experimental treatment of those patients with less than 2 years life expectancy is required
- Insurers may not deny as experimental any service that has successfully completed Phase III of an FDA clinical trial
Click here to view an excerpt of Public Act 99-284
Public Act 01-171
Effective date: January 1, 2002. This bill outlines the following:
- Covers routine care associated with cancer clinical trials for treatment or palliation and Phase III therapeutic intervention trials for the prevention of cancer
- Applies to NIH, National Cancer Institute, FDA, DOD or VA approved trials
- Requires clinical trials to be conducted at several institutions
- Indicates that insurers do not have to pay for costs other entities are reimbursing
- Requires that the Insurance Commissioner adopt regulations implementing requirements for clinical trial forms for enrollment, timeliness for reviewing applications and appeals of denials
- Mandates that routine patient care costs shall not include the cost of an investigational new drug or device that has not been approved for market by the FDA.
The insurer can ask for verification of the following in determining eligibility for coverage of patient care costs:
- Patient meets all selection criteria for clinical trial
- The clinical trial will be beneficial
- Informed consent
- Medical records, protocols including test results and other clinical information utilized by the institution
- Summary of anticipated routine patient care costs in excess of the costs for standard treatment.
- Those services or items that are eligible for reimbursement by an entity other than the insurer or health care center.
The insurer shall request additional information within 5 days of receiving a request for coverage. Several entities in CT (Anthem, NCI, etc..) have developed a form (Request for Coverage of Routine Care Form) for physicians to enroll patients in a CT for submittal to the insurer. The insurer has 5 business days to approve or deny coverage from the date it receives the form and supporting eligibility information it asks for. The insurer has 10 days if it uses an outside independent expert to make the coverage decision. Requests for Phase III prevention trials must be decided within 14 business days.
Click here to view Public Act 01-171 (Substitute Senate Bill 325).
Routine services are services that would otherwise be covered absent a trial; usual and customary care.