Documentation to support billing protocol items/services to insurance must be present in the patient’s medical record, just as for any clinical care. Supporting documentation required by the payor would include a complete, accurate, and detailed record of the care, such as:
trial name, sponsor name and sponsor-assigned Protocol number (required for Medicare)
subject’s condition prior to enrollment in study
reasons for study-related tests/procedures required
treatment rendered during the clinical study
study subject’s response to treatment and plan of future care
written precertification/preauthorization (as required by private payor)
Per the Medicare Program Integrity Manual, to be reasonable and necessary, an item/service must meet the following criteria:
Should be safe and effective
Should not be experimental or investigational
Should be appropriate, including the duration and frequency and provided in accordance with accepted standards of medical practice for the diagnosis or treatment of the beneficiary's condition or to improve the function of a malformed body member
Should be furnished in a setting appropriate to the beneficiary's medical needs and condition
Should be ordered and furnished by qualified personnel
Should meet but not exceed, the beneficiary's medical need
In addition to other routinely required documentation about the service, document the medically reasonable and necessary explanation for each item/service unless it is being done solely for research data collection. The following additional study information must be documented in the patient’s medical record in order to bill for routine costs of a qualified clinical trial:
Before an ancillary service or diagnostic procedure can be executed, an 'order' must be communicated from the treating physician/practitioner requesting that the service/procedure be performed for a beneficiary. An order may be delivered via a written document signed by the treating physician/practitioner, which is hand-delivered, mailed, faxed, or e-mailed to the testing facility/department.
Alternatively, a telephone call by the treating physician/practitioner or his/her office to the testing facility/department may be used. If the order is communicated via telephone, both the treating physician/practitioner or his/her office, and the testing facility/department must document the telephone call in their respective copies of the beneficiary's medical records. While a physician order is not required to be separately signed, the physician must clearly document, in the medical record, his or her intent that the ancillary test or diagnostic procedure be performed.
Incomplete records can result in denial of payment for services billed to Medicare. In order for a claim submitted to Medicare to be valid, there must be sufficient documentation in the provider's or hospital's records to verify the services performed were 'reasonable and necessary' and required the level of care billed.
If there is no documentation or insufficient documentation, then there is no justification for the services or level of care billed. Additionally, if there is insufficient documentation on the claims that have already been paid by Medicare, reimbursement may be considered an overpayment and the funds can be partially or fully recovered.