I recently had the opportunity to speak with an international company about what it takes to bring a new diagnostic test to market in the United States. During the course of our discussion, I began to reflect on just how tricky, time-consuming, and expensive if can be to bring a new test to market here. Based on the huge investments necessary to validate technologies and create collateral in an era of declining reimbursement, we are seeing longer and longer cycles to achieve a justifiable ROI for many of these new tests and technologies. Competition for investor dollars is fierce!
Of course, our process is designed to make sure that any new tests are safe and effective, but do we make it so challenging that some valuable tests never make it to patients and physicians here? Just trying to understand all the pieces to the reimbursement puzzle can be mind boggling ― coverage, coding and compliance being just a few. The roadmap is often not definitive and can vary greatly from payor to payor.
In the discussion referenced above, the diagnostic company has created an in vitro diagnostic test that provides a definitive means of identifying which patients, of those showing certain symptoms, are experiencing a specific condition, so that they can be started on appropriate treatment and additional testing in a timely manner. This particular test has been shown to be more effective than the current protocol in a proof of concept trial.
As the test would be performed by multiple laboratories, it must obtain FDA clearance to be approved for use in the US. This is a lengthy and expensive process. Yet even when FDA clearance is achieved, that alone is not a guarantor of payor coverage. The ability to achieve market adoption of a new diagnostic test is greatly impacted, of course, by the performing provider’s ability to obtain reimbursement for tests performed. This requires positive coverage policies from both Centers for Medicare & Medicaid Services (CMS) and commercial payors.
Although payors and Medicare contractors make independent decisions and the time and level of evidence needed can vary greatly from one to the other, the following criteria must be met for all:
- AV (analytical validity)
- CV (clinical validity)
- CU (clinical utility)
Each Medicare contractor may have different coverage policies for laboratory services. Because the test being considered here would potentially be performed all over the US, the company may have to submit coverage requests to each of the 12 Medicare jurisdictions. While CMS encourages contractors to be as consistent as possible in their coverage determinations, there is still the possibility to see variances.
In addition, it is important to demonstrate clinical adoption in appropriate patient populations to engage payors, let alone achieve positive policy. This is also a requirement to obtain a Category
I CPT code. This is a real chicken and egg situation. You need clinical adoption to engage payors, but you need payor coverage to gain physician adoption. It is also extremely difficult to demonstrate clinical utility when a test has not yet been widely adopted.
In addition to needing FDA clearance and payor coverage, under the Protecting Access to Medicare Act of 2014 (PAMA), FDA cleared tests would also require a new Current Procedural Terminology (CPT) code. Because this test would be performed by multiple laboratories and likely not be considered proprietary, it would need to be a Category I CPT code.
Trials performed outside of the United States often do not meet the requirements for CPT, nor for most payors. So, this means additional time and expenses for in-market peer-reviewed studies. Once a code has been assigned, it will appear on the Clinical Laboratory Fee Schedule (CLFS). The CLFS is binding for Medicare contractors, and most commercial payors base their allowed amounts off a percentage of the CLFS. Actual payment is driven by the right combination of CPT and diagnosis codes.
As this lays out, we’ve clearly set up a system with very high barriers to entry. It’s important to note that the price/reimbursement rates are not based on the clinical value of the test directly. This can make the payback on a new test quite lengthy and makes it imperative to achieve substantial volume and economies of scale.
Have we set up a system that is so complex that we’re missing out on innovative new diagnostics? Considering that 70% of healthcare decisions are guided by diagnostic tests, should we be making it easier for new tests to get to market that help us identify and treat illness and disease earlier and more effectively?
At the very least under the current market requirements, international diagnostic companies need to partner with advisors that deeply understand the U.S. process and requirements, and can help set realistic expectations for reimbursement to evaluate the economics of market expansion into the U.S.