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As a clinical trial study coordinator and the director of a large clinical trials office, I know that nurses have to deal with many more regulations and compliance issues than ever before to provide nursing care. In addition, nurses must know more today than they have ever had to know in regards to billing for care and services, especially when a patient is participating in a clinical trial. Clinical trials have evolved from a lightly regulated part of clinical practice to a complex and strictly regulated environment. Informed consent for clinical trials were simple, three-to-four-page documents that required a patient’s signature. Nurses did not have to worry about who covered the costs for items and services provided to participants. Nor was ethical scrutiny needed as a critical part of the decision regarding a patient’s participation in a particular study. I have seen all that change in the more than 30 years since I began my career as an oncology nurse.
The need for communication is paramount. In this context, communication means sharing the clinical trial information with all parties involved in the care of the patient, including the facility conducting the trial; the primary care provider; and any hospital, clinic, laboratory, clinician, or technician that may provide services. This article explores the terms used in clinical trials and some of the hidden challenges faced when communicating clinical trial information throughout the continuum of patient care.
COVERAGE ANALYSIS AND INFORMED CONSENT
Understanding the terms used in the billing process is the first step. (The italicized terms in this article are defined in Table 1.) The coverage analysis is the document that identifies who the appropriate payor is for each item and service provided to participants in a clinical trial, as stated in the protocol and schedule of events. It does not guarantee payment from a provider but documents the intent to bill for items and services not supported by established regulations and guidelines for the treatment of the patient’s cancer.
The coverage analysis can also be used by facilities to determine budgetary needs, contract negotiations (for example, between the facility conducting the trial and the clinical trial sponsor), and consent-form wording. This documentation is necessary for all studies, in particular cooperative group trials in which all usual routine costs are billed to a private insurance or Medicare payor.
The informed consent designed by the facility conducting the clinical trial, often a document modified from a template provided by the trial sponsor, states the items and services that are the patient’s financial responsibility, and is an important guide for billing. It is carefully worded and informs patients of their true costs; promised services must match budgeted allocations and the coverage analysis. Clinical trial nurses and principal investigators should discuss the items and services that are the participants’ financial responsibility with the patient and also document the discussion in the consent note. (Preauthorization and certification from the patient’s insurance company should be obtained prior to registration.) The discussion should answer the following questions for the patient.
• What are my costs to participate in the clinical trial?
• What are my co-payments for the treatment?
• Why will my bills be sent to Medicare instead of my Medicare Advantage Plan?
• Could I be financially responsible for anything that is billed to my insurance company in the trial?