When preparing a billing plan for a clinical trial, follow the Medicare model to make the best case for reimbursement from other payers, a clinical research compliance expert advises.

Medicare’s rules “are considered the gold standard by which many commercial payers base their coverage decisions,” said Nancy Howard of NRH Compliance Partners in a recent CenterWatch webinar. “Medicare drives most reimbursement rules in the United States,” Howard said. “It’s just not practical to do a coverage analysis for every potential payer.”

A trial’s coverage analysis (CA) should use Medicare’s criteria for determining medical necessity, she said. Under those rules, a billable item or service must be necessary to diagnose or treat an illness or injury, condition, disease or its symptoms, and must meet accepted medical standards.

Medical necessity must be clear in all trial documentation, Howard said. “The coverage analysis prepares the way for billing,” she said. “When you are actually billing, the medical necessity has to be supported by documentation in the medical record.”

To begin the process of documentation, Howard recommended collecting all of the items in the protocol that are considered billable. But the protocol doesn’t always list everything that is needed, she explained. “You are going to look in the footnotes and the visit documentation and see what items might be considered billable. Some of them have to be broken out.” For instance, a “test” required by the protocol in reality may be several distinct tests. This information should be documented before the trial begins.

Each billable item should be noted in the CA’s billable grid, with an explanation of its medical necessity entered in the comments section of the grid. Consider whether the item or service is medically appropriate at the given frequency and duration, Howard advised, and whether it is medically necessary for all trial participants. The explanation should be supported with federal regulations, coverage determinations, benefit policies and an explanation of generally accepted standards of medical practice.

Howard provided an example of a billable grid in which items are listed individually, with an indication of who will pay for each item. She identifies the payer responsible with a code, such as Q0 or Q1. If the trial sponsor will pay for the item, the code is S, along with the statement, “Research purposes only; sponsor to pay.”

She also recommended adding a general statement to the CA such as “This Medicare statement is intended as a general guideline for use in determining which items and services are billable to Medicare based upon current benefit policies, coverage determinations and federal guidelines.” Howard also includes on each line item on the billable grid a statement that “all items and services that are billable to Medicare must be supported by medical necessity.”

Beyond the CA and its billable grid, everything relating to billing must be included in the medical record, Howard emphasized. The legal health record is the documentation of the patient’s health information created by the healthcare organization. It has to reflect the medical necessity for the care that is provided, she said. “You have to understand that clinical research documents that the investigator has maintained in the study files are not part of the legal health record.” Research documents or data to include in the legal health record include the informed consent form and the source data from research documents used for clinical decisionmaking.

In addition, since benefits are available only when a covered person is clinically eligible for participation in the qualifying clinical trial, ensure that study consent, study eligibility requirements, study participation and drug/therapy dispensed are documented in the patient’s medical record, she said.

Finally, when the time comes to bill for an item or service, documentation must be reviewed to confirm that the patient actually received the allowed services, the allowed services were provided at the level billed and medical necessity is documented correctly so each charge can be coded appropriately.