Budget & Calendar Prep Considerations

If this is a device study, do you have a CMS approval letter from the sponsor?

1. If not, request one and send it to your coverage analyst.

2. If the sponsor states they did not receive CMS approval, EVERYTHING must be included in the budget since EVERYTHING will be billed to the study. Insurance will not cover anything associated with a study that does not have CMS approval.

Studies that are qualified under Medicare’s clinical trial policy allow for items and services for the prevention, diagnosis, or treatment of complications to be billed to insurance. From a billing compliance standpoint, this is easier to manage operationally for coordinators who are tasked with identifying the procedures when they occur and the billing staff for capturing the charges. Charges that are not identified by WU or BJC billers could be billed to insurance. If they are also billed to the sponsor, the school and/or hospital would be submitting a “false claim” and can be subject to extensive fines. If the Sponsor or PI elect to have the sponsor cover these types of services, it is important that the exact service is identified in the CTA(a) as well as the exact circumstances/conditions in which the Sponsor is agreeing to pay(b).

1. Examples: Make sure there is a distinction between the service vs. coordinator effort and between the actual lab procedures vs. sample prep for central labs.

2. If including chemistry labs in your budget, search the protocol for chemistry and other miscellaneous tests that aren’t included in a panel at BJC (i.e. magnesium, direct & indirect bilirubin, phosphorus, GGT, uric acid, LDH, lipids, triglycerides, cholesterol, CRP, Serum HCG, urine HCG, CK).

3. The phrase “Invoiceable if not standard of care” translates to invoiceable any time the services is provided from date of consent to date off study. If this is not the intent, the language should provide more detail. For example, “Invoiceable if not standard of care at Screening” or “Invoiceable during treatment period.”

Which labs will be sent to a central lab? Which will be done locally? Will they ever be sent to central lab AND done locally?

1. If the consent form states that the subject will not be billed for any services, any local labs done for the study should be accounted for in the budget.

2. If tests may be done locally on a PRN basis AND the sponsor is not paying for them, make sure the ICF includes text such as, “This study includes tests or procedures that are part of clinical care and may be billed to their insurance company; if this occurs you may be responsible for some or all of the cost of some procedures.”

Are there insurance billable services required by the study that are not in the protocol schedule of events? Review the body of the protocol, including the inclusion/exclusion criteria.

List services (and specific visits) that will take place in a designated research area. This will help to ensure the calendar is representative of the way the study will run and will be built as expected by the FC, while ensuring compliance risks are accounted for.