Most buyers of clinical trial insurance look for broad coverage at an affordable, predictable cost. The difference in coverage offered by insurance companies can be confusing and the process to obtain coverage can be time-consuming. Medmarc offers blanket coverage for all clinical trials started during the policy period and eliminates the uncertainty about insurance costs by charging a “flat” premium that is not subject to audit. Clinical trial sponsors are free to begin their work immediately—without additional paperwork, costs or unforeseen delays. In contrast, the process used and coverage offered by many insurance companies can result in delayed trials, unexpected coverage gaps and uncertainty as to the ultimate insurance costs.
Blanket Coverage vs. Coverage by Endorsement
The breadth of clinical trial coverage depends on whether trials are covered on a scheduled or a blanket basis.
Coverage by Endorsement Requires That All Trials Be Identified. Some carriers provide clinical trial coverage by an endorsement to the products liability-completed operations policy. If a particular trial is not specified and scheduled on the endorsement, it is not covered.
Blanket Coverage Is More Inclusive. In contrast, clinical trial coverage provided on a “blanket” basis means that all trials in progress at the policy inception date and started during the policy period are automatically covered. Trials are not individually scheduled, so no endorsement to the policy is necessary. Medmarc’s products liability policy provides blanket coverage, which is broad and mitigates the potential for coverage gaps.
Treatment of New Trials
New trials that begin during the policy period are handled differently depending on the coverage provided.
Coverage by Endorsement Means New Trials Are Subject to Underwriting Review. Insurance policies that require a schedule of clinical trials do not provide coverage of new trials unless the insurer is notified, in advance, of the trial and agrees to add the specific trial to the policy. Thus, additional paperwork and data will be required by the insurance company prior to extending coverage. This means there may be some lead time prior to coverage becoming effective, which may mean delaying a trial start date. Failure to report the new trial under such policies may leave a sponsor without coverage. Even with notice, the carrier may decline to add coverage for the new trial. Adding the new trial also may have premium implications for the sponsor, adding to insurance costs.
New Trials are Covered Automatically if Done on a Blanket Basis. Blanket coverage works differently. New trials that begin mid-term are automatically covered and there are no reporting requirements or additional premium charges imposed by a new trial. Since Medmarc provides blanket coverage, failure to report a new trial does not jeopardize coverage for the new trial.
Changes to Protocols
Changes to protocols that occur during the course of the trial also may impact coverage.
Notification of Protocols Changes May Be Required. Some insurance companies require notification of changes to protocols and if they don’t receive such notifications, trials may not be covered should a claim arise. As a result, it is important that the clinical trial sponsor notify its carrier of any protocol changes.
With Blanket Coverage There Are No Reporting Requirements. Under blanket coverage, it is understood and expected that trial protocols may change and changes to protocols do not add any additional reporting requirements, nor will they jeopardize coverage.
Increasing the number of participants may impact both coverage and premium if the policy is subject to audit.
Additional Audit Premium May Be Assessed at the End of the Policy Period. As part of the insurance application process, a clinical trial sponsor must provide an estimate of the number of participants taking part in each clinical trial to be covered. Many insurers use the sponsor’s estimate to set a “per participant” charge and to calculate a deposit premium. This type of policy is termed an “auditable” policy, which means the final premium to be charged will be determined by an audit at the end of the policy period. An auditable policy has several downsides. First, at the end of the policy period, the sponsor must submit updated data regarding the trials conducted during the period. Collecting and assembling the data can be a time-consuming process, especially when there are multiple clinical trials being conducted and at different sites. Audits also can be cumbersome and the insurer may require the data to be broken down by study, phase, site and participant population, etc. Lastly, any increase in the actual number of participants compared to the original estimate generally means an additional, unexpected, unbudgeted premium charge.
Non-Auditable Policies Translate into Predictable Insurance Costs. In contrast, non-auditable policies are not rated based on the number of participants. Although the number of participants factors into the premium charged, the initial premium charged is not subject to change. Since insurance costs are known at the outset, additional, unforeseen charges are avoided. Medmarc’s non-auditable policy eliminates the extra expense and administrative burden of submitting additional trial data at the end of the policy term and allows for certainty in pricing and predictability when establishing trial budgets.
All statements and opinions in this publication are for informational and educational purposes only. None of the information presented should be considered as offering legal advice or legal opinion. We are not liable for any errors, inaccuracies or omissions. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered by Medmarc Insurance Group, the terms and conditions of the actual policy will apply.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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