Subcontracting a procedure without losing the payment chain: flat-fee exhibits for local specialists

Why a single procedure creates a payment problem

A subcontracted procedure sits between three parties. The sponsor funds the study, the site conducts it under the protocol, and the specialist performs one defined task inside that protocol. When nobody writes down who pays whom, for what, and on what evidence, each party fills the gap with a different assumption.

The specialist may expect to bill for time, supplies, and a follow-up visit as separate charges. The site may assume the quoted price covered everything. The sponsor may receive an invoice it cannot match to any line in the study budget. None of this comes from bad intent. It comes from treating a research procedure like an ordinary clinical referral, when it is not one. A research procedure is performed because the protocol requires it, on a participant the site enrolled, under the oversight of the principal investigator (PI).

The principle: one fee, one payer, one paper trail

The structure I recommend has three parts. First, price the work as a flat fee per completed procedure. The fee should be all-inclusive, covering the specialist's time, ordinary supplies, the procedure room if the work happens at the specialist's office, and the routine documentation the study requires. If the protocol may require an additional step, price it separately in advance, or state that it requires written approval first.

Second, the site pays the specialist. The sponsor should not pay the specialist directly. When the sponsor pays the site under the clinical trial agreement, and the site pays the specialist under the services agreement, each payment matches one contract and one budget, and the chain can be audited end to end. A direct sponsor-to-specialist payment breaks that chain and leaves the site accountable for work it did not purchase.

Third, the work is research-only. The procedure is never billed to the participant's health insurance, and it is never billed to the participant. Double billing, where a protocol-required procedure is charged both to the study and to an insurer, is a serious compliance failure. State that rule in the agreement itself, not only in conversation.

For illustration only, a site might agree on a flat fee of 350 dollars per completed biopsy, invoiced once a month, rather than a visit fee plus separate charges for supplies and documentation. That figure shows structure, not a benchmark for what any procedure should cost.

Put the fee in the study budget and in an exhibit

A verbal rate is not enough. The fee belongs in two places that reinforce each other.

The first is the study budget. Raise the subcontracted procedure during budget negotiation, as its own identifiable line, so the sponsor funds it knowingly. If you discover the need after the budget is signed, ask for an amendment before the work begins. An invoice that matches no budget line becomes a dispute, even when everyone agrees the work was done.

The second is an exhibit to the services agreement between the site and the specialist. The main agreement carries the general legal terms. The exhibit carries the operational truth for this study: what the procedure is, what counts as complete, what the site pays, and what the specialist must deliver.

What a flat-fee exhibit should contain

A useful exhibit should contain at least the following six elements.

• Procedure definition. Name the procedure precisely as the protocol defines it, including the study, any required technique or equipment, where it will be performed, and who supplies the materials. If the site provides the biopsy kit and specimen shipping, say so. If the specialist provides them, say that instead.
• Completion criteria. Define what completed means. For a biopsy, completion might require the procedure performed according to the protocol, the specimen labeled and handed over as specified, and the procedure note delivered within a stated number of business days. The fee is paid per completed procedure, not per attempt or per appointment. Address in advance what happens if a procedure is started but cannot be completed for a clinical reason.
• Fee. State the flat fee, state that it is all-inclusive, and list anything expressly excluded. State also that the fee will not change during the study unless both parties sign a written amendment.
• Invoicing cadence. Set a predictable rhythm, such as monthly invoicing in arrears, with each invoice listing the study, the number of completed procedures, and a participant identifier that protects privacy while allowing verification against source records. Set the payment window as well, for example thirty days from a correct invoice.
• Documentation duties. List what the specialist must return: the signed procedure note, any required source documents, confirmation of training on the protocol and on good clinical practice, and a current license and credentials file. State how adverse events observed during the procedure are communicated to the PI, and how quickly. Confirm that the specialist will be listed on the delegation log, will follow the site's applicable standard operating procedure (SOP) requirements, and will cooperate with monitoring and audits of the delegated work.
• Termination. Say how either party can end the arrangement, with what notice, and what happens to procedures already scheduled, documentation already owed, and fees already earned. A thirty-day notice period usually works. Fees for completed procedures should remain payable, and documentation duties for them should survive termination.

You may also need language on confidentiality, record retention, and review by the institutional review board (IRB) where the arrangement requires it.

Before you sign: capacity and competing enrollment

Before you sign, ask the specialist two practical questions.

The first is about capacity. How many procedures can the practice realistically perform each week, how far out is the schedule booked, and who covers the work when the specialist is away? A protocol often requires a procedure inside a narrow visit window. A willing specialist whose next opening is six weeks away will still cause missed windows and protocol deviations. Agree on scheduling lead time in the exhibit if the windows are tight.

The second is about competing enrollment. Many local specialists now run trials of their own. Ask whether the specialist is conducting, or planning, a study that enrolls the same kind of participants for the same condition. If so, talk openly about how referrals will be handled, so a participant who belongs in your study is not diverted into theirs, and the reverse. This is a conflict to surface while it can still be managed in writing, through disclosure and a clear agreement that each study's participants stay with that study.

Check credentials at the same time: current licensure, relevant experience, and any exclusion or debarment. Document the check and file it with the study records.

How this works in practice

At Amavita Research Services, our Miami cardiovascular trial site, we care for more than 18,000 active cardiology patients, and our record includes zero Food and Drug Administration (FDA) Form 483 findings. That record comes from treating small arrangements with the same discipline as large ones. I serve as chief executive officer (CEO) of Amavita Research Services and as CEO of bioaccess, a first-in-human contract research organization (CRO), and the lesson is the same on both sides of the industry: the arrangements that cause trouble are rarely the complex ones. They are the informal ones nobody wrote down.

A single biopsy, injection, or imaging read can be subcontracted cleanly. Pay a flat fee for a completed procedure. Keep the site in the middle of the payment chain. Keep insurance and the participant out of it entirely. Fund the fee in the study budget and define it in an exhibit.

Julio G. Martinez-Clark is chief executive officer (CEO) of Amavita Research Services, a Miami cardiovascular trial site, and chief executive officer (CEO) of bioaccess, a first-in-human contract research organization (CRO).