November 13, 2015

UAMS Clinical Trials Medicare Coverage Analyses

Dec. 3, 2015 | The Medicare National Coverage Determination (NCD) for Clinical Trials outlines items and services that are not billable to Medicare. These include “items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial.”  The NCD provides no further clarification for this language.

Historically UAMS has not negotiated when a sponsor offered to pay for an item or service; as a result that offer was accepted as a term of the final agreement. An item or service that is paid by the sponsor is not billable to Medicare and must be designated “research,” even if it would otherwise be considered conventional care.

Based upon a recent review of our process with the Office of Institutional Compliance, UAMS has determined that the sponsor’s offer to pay for such items and services is merely a part of the overall negotiation of the final clinical trial agreement. A number of statements, FAQs, and other language from CMS was analyzed as a part of this review, including the following from a proposed replacement Clinical Trial NCD:  “Medicare does not cover usual patient care when such care is provided free to the Medicare beneficiary or when the study sponsor agreement with investigator sites or the informed consent documents provided to the patient specify that the care will be provided free to participants (§1862(a)(2); 42 CFR 411.4).”

Accordingly, investigators will be able to use the sponsor exhibit as a guide in negotiations rather than something that must be accepted exactly as written. However, once negotiations are complete and the contract is signed, the final signed contract must be followed exactly as written. Once signed, these items will be analyzed as they have been, according to language in the contract, protocol and consent.

The TRI Research Finance Team will now perform coverage analyses in which they initially do their analyses based on the protocol, consent, sponsor exhibit and CTA. However, the team will also provide notes regarding any item or service subject to a proposed sponsor payment that may be billable to Medicare or other payors as conventional care. The research team will have this information available for their negotiations with the sponsor. The final coverage determination for items and services will occur upon completion of the signed clinical trial agreement.


One issue has arisen under this new approach. Billing rules may limit a sponsor’s ability to pay for various activities that occur during certain visits or procedures. For example, where a visit/procedure is bundled, that is, where the services may not be itemized individually for payment, neither the sponsor nor UAMS may pick and choose which items can be invoiced to the sponsor and which can be billed as routine care. The TRI Research Finance Team will identify these instances for investigators as part of the coverage analysis.

For any questions related to this new approach please contact Kennetha Newman, TRI program coordinator, at 501-526-7665.