Tamara Rook & Marielle Lejcher on Why Timing Is Everything in Market Access and Regulatory Strategy

In this edition of The Rubrum Exchange, Tamara Rook, vice president of market access, and Marielle Lejcher, a global regulatory leader in our FDA practice — sat down to talk about a pattern they both see constantly: companies that call for help after the problem has already taken root. Their conversation, lightly edited for length and clarity, is below.

What’s the question you wish every CEO asked six months before they find you?

Tamara Rook: I always appreciate speaking to CEOs and business leaders early in their product planning process, when there’s still time to develop a high-level reimbursement strategy. A lot of times when we get a call, it’s because of a problem that may be too far along to fix in an expedient manner. The questions many people don’t know to ask are the fundamentals: Does my product have a reimbursement pathway? Is there an existing code? Is there existing payment, and will that payment work? Will my technology fit an existing code? Is there coverage that will apply? When I get a call early, that’s the analysis we can do — and it’s the best use of a company’s time and money.

Marielle Lejcher: It’s very similar on the regulatory side. By the time regulatory becomes an urgent topic, so many foundational decisions have already been made — intended use, product claims, design controls, clinical strategy, reimbursement strategy, software, global strategy. Engaging regulatory and market access expertise early and often is what shapes a strong go-to-market strategy. It reduces rework, avoids unnecessary costs, and aligns business objectives and timelines with FDA’s expectations. Clients don’t always want to spend the money early, but our advice is consistent: come to regulatory and market access early and often and keep realigning your strategy.

Is there a decision that’s especially difficult to undo later?

Marielle: You can always walk back some of your strategy, but the critical foundation is the intended use — the indications for use. Everything develops from there. Sometimes you have to pivot: new guidelines come out, other devices are cleared, and you have to look at those special controls and decision summaries and shift. But redoing the entire thing means going back to the intended use, and that is very costly and takes a lot of time.

Tamara: I agree. Medicare uses that intended use, too. Say you have a product in the durable medical equipment space and you need a new HCPCS code — Medicare is going to look at your intended use and your instructions for use and base the definition of your code, and how that code will be used, on them. I’ve had clients want to change something later, and CMS always points back to that intended use. Unless something changes with FDA, it carries forward into your reimbursement and coding strategy.

What’s the most common misconception you encounter?

Tamara: Assumptions. There’s often an assumption that if you develop a new medtech product and FDA clears it, CMS will cover and pay for it — and so will commercial payers. That is not always the case, and it’s something we unwind quite a bit.

Marielle: And that’s often because [companies] don’t fully understand the difference between clinical validity and clinical utility. They think that because a product is safe and effective, it will get paid for. The real question payers are asking is: did that device change health outcomes?

Tamara: FDA and CMS are two different stakeholders with two different areas of focus. Think about “reasonable and necessary,” which is what CMS is looking for, versus safety and effectiveness. Those are two different lenses.

Marielle: The other big one: people think FDA regulatory is just about preparing submissions for clearance or approval. There’s a long-running joke that regulatory is the “sales prevention team.” In reality, we’re quite the opposite — a business enabler that helps companies make informed decisions, manage risk, and accelerate market access. Regulatory is involved in every aspect of product development, from defining intended use through evidence generation and commercialization planning.

Tamara: What frustrates people is that the process isn’t linear. It’s not “do A, B, C, and D, and CMS says yes.” There’s no secret sauce, because every technology is different and every patient indication is different. It takes real strategy, review, and analysis to get where you want to be.

Does this surprise even large, established companies?

Tamara: It’s everyone — it’s not one type of organization. It depends on the individual in charge, their experience, and which technologies they’ve worked with. I’ve seen it across the board.

Marielle: Regulatory strategy and market access are genuinely complex, and the regulations, guidelines, and policies around them are constantly evolving. What worked five years ago may not work today. If a company doesn’t recalibrate its strategy over the product lifecycle, that’s when urgent issues start.

Tamara: And reimbursement changes every year. Just because CMS has always covered a product category at a certain level doesn’t mean that continues into infinity. Technology categories can be re-evaluated for coverage and payment. Staying on top of the updates is something not everyone tracks — but everyone should.

Rubrum Advising helps innovators navigate the policy landscape shaping market access and reimbursement. To learn more about working with our team, drop us a line.