InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.
Patients are entitled to understand if their participation in a clinical trial will cost them money. The process of obtaining their informed consent must therefore include information relevant to subject costs and billing. Consider four categories of cost concern: treatment and diagnosis for research-related injury, lost wages, travel-related expenses, and healthcare items and services delivered during the trial. This last category can be an area of confusion for IRBs, investigators, and study teams, except in those cases when 100% of charges are either covered (or not) by the sponsor. I mentioned this topic in one sentence in the previous InSites blog, but it’s worth fleshing it out further.
FDA regulations require (when appropriate), disclosure during informed consent of: Any additional costs to the subject that may result from participation in the research (21 CFR 50.25(b)(3)). Some interpret this to mean that the informed consent form (ICF) must include a line-by-line description of all items and services listed throughout the trial, indicating in spreadsheet fashion, which charges will be paid by them, their insurer, the sponsor, or other (if any). At the other end of the spectrum is a minimalist approach where the ICF to simply states: You or your insurance company will be billed in the usual manner.
Although the detailed approach sounds good – because it provides a great deal of information to the subject prior to decision-making – it should not be done . The problem with disclosing such detail is a lack of knowledge. IRBs can be sure of the charges covered by the sponsor, because these are contractual. However, for all other charges, a subject-by-subject analysis is required to determine which costs insurance will cover and which will be the responsibility of the subject. Prior to enrollment, IRBs cannot be certain which medical charges will be the subject’s responsibility.
There are many insurance plans, all are different, and payment depends on a patient’s history. Costs covered by one plan may be subject to limitations in another. Medicare coverage cannot predict commercial insurance coverage. Costs vary depending on whether a service or provider is in-plan or not, subject to a deductible, subject to the maximum out of pocket payment, and company opinions on medical necessity. Any specific information given to subjects on insurance coverage can only be inaccurate and misleading. Even Medicare beneficiaries can be misled, depending on whether they participate in a Medicare Advantage plan, and on regional variability of Medicare contractors. Lastly, there are the uninsured, for whom coverage and price discounts do not apply. How much will it cost them?
Hospitals that have adopted a policy of routinely providing detailed billing information in the ICF should abandon that approach. However, the minimalist approach is also insufficient and likely to be misleading, too.
What is needed is an informed consent process that helps people gain reasonable understanding of what costs are known and unknown. The ICF itself can explain which items and services the sponsor/office/hospital will cover, but should also explain that the subject (and his or her insurance company if appropriate) will be billed for routine care. The ICF should also strongly encourage the subject to engage the study team for more information (for sample ICF language, please email the author). The process should include the option of financial counseling for further information.
For any study where routine care and research are co-mingled, there is no practicable way for an ICF to accurately predict all subjects’ out-of-pocket medical costs. Instead, implement an effective process that encourages and supports meaningful dialogue, and document those discussions in the record before the subject signs the ICF.
InSites is a monthly column written by TIRS Editorial Board member Stuart Horowitz, PhD, MBA. Dr. Horowitz is President, Institutions & Institutional Services at WIRB-Copernicus Group.