Selected Q&A from the Clinical Research & Health Insurance book launch session hosted by Momentum Events, April 16, 2026.
By Ryan Meade and Chris Conway, with Kelly Willenberg. Edited by Momentum Events.
On April 16, 2026, 333 clinical research billing and compliance professionals joined Kelly Willenberg, Ryan Meade, and Chris Conway for a virtual session to launch Ryan and Chris's new book, Clinical Research and Health Insurance. The chat filled up fast. Questions came in from coverage analysts, revenue cycle teams, billing reviewers, and colleagues on the sponsor side. Some were big-picture. Some were surgical.
This post pulls five of those questions out of the noise. Each one reflects an issue we are hearing from the field more than once. The answers below are drawn from the session itself, lightly edited for length and clarity. If you want the full context, the recording is available on request and the book goes much deeper.
"The change in reimbursement trend away from line items was mostly federal payers. Did you find that most commercial payers also moved this way?"
Asked by Rene Jooste
Short answer: yes, and the number is higher than most teams assume.
Chris: Medicare is the only payer that really writes this down, and Medicare is the largest insurer in the country. As Medicare goes, so goes everybody else. Medicare jumped in first with the OPPS logic and over time the rest of the industry followed. There is no mandate to follow, it is not perfectly uniform, but on the outpatient side the commercial industry has tracked Medicare's lead just like it did on the inpatient side.
Ryan: In audit and investigation work, roughly 75 percent of commercial payers pay for research services almost the way Medicare does. Medicare Advantage plans use a managed care approach, which is the same posture under a different name. The major commercial payers either own Medicare Advantage lines or process Medicare claims, so they know the trends and they know hospitals are budgeting against them.
One note for pediatric organizations. Our advice used to be stick with Medicare even if your Medicare volume is around two percent. With the changes in reimbursement, that is now a live question. If you are a standalone pediatric hospital, running coverage analysis and budgeting against Medicaid is a legitimate option today, because commercial insurance is paying less and in many places is starting to look more like Medicaid.
"How do you get the sponsors to just pay pass-through costs for big-ticket items, rather than a set amount, so that each individual subject's situation is covered?"
Asked by bmartin (chat handle)
Ryan: Be careful here. Current coverage analyses are often enormous, trying to anticipate everything that could happen. That is the road to nowhere. Anything ordered off the road of the schedule of events or schedule of assessments carries the presumption that the physician ordered it for medical necessity, not for the study. The moment you start chasing money for every possible scenario, the scope becomes almost infinite.
A better approach is to pull back and focus on what the study actually requires. Get your budget tied down on what the sponsor will pay for required services. If you are taking lump sums or milestone payments, get contractual language that limits the sponsor payment to services that are not covered under NCD 310.1 or are not routine costs. This is educational, not legal advice over Zoom, but that contract line matters.
The bigger point is that chasing hypotheticals burns energy you could spend on what you can actually know and control.
"I am working to understand the bundling on bone marrow biopsies, and there are APC status indicators (Q2) applied to some of the ancillary testing like flow cytometry. Can you speak to what this Q2 indicator on flow cytometry applies to the concept of covered not paid?"
Asked by Kathy Kronmal
Chris: The Q2 status indicator signals a conditionally packaged service. What you will often see with flow cytometry is that if it shows up on the same claim as the biopsy, you will not receive separate reimbursement for it. A lot of services show up on a claim alongside a biopsy that carry no separate payment.
This is a budgeting challenge more than a coverage analysis challenge. If a sponsor is paying for a biopsy, the real question is "what does a biopsy actually cost us?" You cannot look only at the biopsy line. The ancillary services are part of the true cost. A little data diving with your clinical staff and revenue cycle team on what normally shows up around those codes will let you price them properly and make sure the sponsor payment is sufficient.
Ryan added context on the language itself. Medicare is a large enough program that it recycles letter codes across claims processing rules and payment formulas. Q0, Q1, and Q2 are clinical trial modifiers people know from physician and outpatient claims. Under the outpatient prospective payment system, those same letters are used as status indicators, and they mean something completely different. The overlap is confusing, and it is real.
"The more we have the sponsor pay for, the more we have to catch those charges going out. How do we make sure all those potential codes are caught by reviewers? The codes will matter more."
Asked by Denise Quint
Ryan: The answer is to start from remittances. Look at what your organization actually gets paid. Charges will not tell you what you collect. We use the phrase "remittance reality" for this.
Two practical implications.
First, there is nothing wrong with budgeting based on coverage, but these days you are probably leaving money on the table and subsidizing costs the sponsor should be paying. Look at what you actually get paid and use that data to negotiate. If services are covered but your payers are not paying you for them, learn that, put it into your budgeting tool, and ask the sponsor to pay. If services are covered and paid, check whether the sponsor is offering more than what you would collect from Medicare.
Second, claims data helps on the front end too. You will see patterns. The protocol might describe imaging in the abstract, but the reality is that 98 times out of 100 a CT of the chest, abdomen, and pelvis comes through on two specific codes. Knowing what the protocol actually turns into at the claim level tightens your coverage analysis and makes back-end review far simpler.
One related trend worth flagging: sponsors are increasingly moving big-ticket items to separately invoiceable services rather than folding them into milestone payments. That is good for sites, but only if you actually invoice. Some sponsors are effectively banking on the fact that sites forget.
"Coming from the sponsor side, we have observed that investigators at a research site serving as sponsor-investigators sometimes send ICFs stating that routine care is billed to the patient or insurance, and study activities will not be billed. This is different from what sites tell us."
Asked by Kim New
Ryan: When you step into the shoes of the institution rather than the individual investigator, this makes sense. Research is usually controlled by the hospital or the legal entity where it happens, not by the physician. The doctor is the quarterback. The hospital is the owner of the team.
Informed consent language sometimes overstates what is promised free. When that happens, the hospital reels it back, because they know their local patient population might misread the promise. What you commonly see is neutral language stating that services that are routine may be billed to the patient or insurer, and services that are for the study only will not be. That language is anchored in the regulation, which requires the hospital to disclose added costs.
Sponsors are seeing that neutral language come back because it keeps organizations from over-promising and it sets patient expectations at the right level. The site is matching what it can actually deliver against what the rules require it to disclose.
Thank you to the 333 professionals who joined us last week and kept the chat full of questions. If you were registered for the February summit and could not attend the makeup session live, the recording is available on request. If you have not picked up the book yet, Clinical Research and Health Insurance is available on Amazon.
Upcoming with Kelly Willenberg & Associates and Momentum Events:
We will see you there.
Editor's note: Quoted answers above are drawn from the live session audio and lightly edited for length and readability. Final copy should be reviewed and approved by Ryan Meade and Chris Conway prior to publication.