CLINICAL TRIAL MEDICAL INSURANCE

Specialty Coverage including “pre-existing conditions”.

Affordable specialty insurance solutions providing valuable benefits

specifically to meet the needs of the Foreign Clinical Trials.

Travel Accident and Illness for Foreign Clinical Trials Including “Pre-existing Conditions” Coverage

With the cooperation of the pharmaceutical industry, Custom Assurance Placements has developed a special program designed specifically for clients of International Clinical Trials, The innovative features of this product help overcome a number of the problems that typically face the sponsors of foreign clinical trials.

The new specialized coverage includes travel medical insurance for people travelling out of their home country to participate in clinical trials. Cover is included for medical emergencies that occur during travel as well as for the complications that could arise from pre-existing conditions.

There is a need for this specialized cover because international travel medical insurance policies generally have exclusions for a) “those travelling to receive medical care” and b) for pre-existing medical conditions. These exclusions can present major difficulties for trial sponsors.

The special coverage provides the following benefits for clinical trial sponsors:

Coverage for trial subjects travelling overseas to receive medical care;
Coverage for pre-existing medical conditions;
Meets contractual obligations imposed by the study facility regarding sponsor liability for the medical care costs of the study subject;
Keeps the sponsors out of the medical claims business while conducting a trial and transfers the claim processing to an experienced international insurer;
Reduces the total cost to sponsors by utilizing the insurer’s international claims network to negotiate with local hospitals.

The product has generated hundreds of thousands of dollars in savings for its launch sponsor, the product is now being formally offered to other Pharmas.

Case Study:

A trial participant had a claim for the illness being studied that would have been excluded by other insurance plans or in some instances, covered by the Pharma directly as contractually obligated with the study facility. The participant needed serious medical care while overseas taking part in a trial. The “pre-existing” condition medical expenses would typically be the liability of the sponsor as taken on by contract and dealing with the claims and medical bills would fall to the manager of the trial or to the pharma/CRO.

With the specialized product, claims were submitted to the insurer. The claim was so large that the pre-existing coverage limits were exceeded as the claim was nearly $1 million. After cost containment and application of the pre-existing condition coverage limits, the liability of the pharma was reduced by $600,000. In addition, the insurer’s medical claims experts were able to handle the adjustment of the claim with international network re-pricing.

The Pharma was delighted as this saving offset the cost paid for the insurance coverage for all the participants in that year! Anonymity of the participant was maintained and Pharma liability was mitigated.

Contact Tracy Simons at tsimons@customassurance.com

Please Note: This is a brief description of services provided through and benefits of the policy and is not an insurance contract. please refer to the Policy for details on the terms and conditions.