CLN - Focus on Molecular Diagnostics
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Getting proper reimbursement to conduct genetic and molecular testing for infectious disease has become an increasing concern for laboratories. CLN spoke with Ashley Zarling, director of business development and marketing with Doc Lab, for tips and insight. Zarling provides consulting to laboratory professionals in physicians’ offices and reference laboratories to help them communicate effectively with payers and navigate the reimbursement process.
The content of this interview was edited for length and clarity.
The root cause is we don’t have enough data to create a Category 1 CPT code, which works as a protection and a commercialization strategy for laboratories. When you’re billing under nondescript codes, there’s always a risk that a payer may redefine the code in a way that’s unfavorable to you. So having a good CPT coding strategy to get reimbursed fairly is paramount.
Second, it’s important to consider whether your tests are being utilized in medically necessary ways that are recognized by the industry. It’s always a good idea to internally audit your tests to ensure their use-case is defensible.
Yes. Manufacturers are required to get approval from the Food and Drug Administration (FDA) to sell in vitro diagnostics. Thus, historically, many manufacturers skipped trials and sold components of their tests to labs that then used these components to create laboratory developed tests. This moved the requirement to run trials off the manufacturer and onto the lab. Because this type of testing is cutting-edge, the science often advances faster than coding can be established, necessitating the use of nondescript CPT codes.
Labs were able to get reimbursed really well for this testing for a long time. But while patients are still getting serviced and providers have the benefit of quicker, more accurate testing, laboratories are now struggling to get paid in full for these tests.
Labs are closing that don’t typically have the volume to make money off of blood tests, but that do have enough volume to make money off of PCR testing. As a more cutting-edge science, this infectious disease testing had somewhat decent profit margins.
At the end of the day, these labs are for-profit. They’re not getting grants from the government. So laboratorians are losing their jobs. Sales reps are losing their jobs. And it’s not a small number.
Moreover, the impact can be far more dire than losing labs. If patients lose access to molecular and genetic testing for infectious disease, there are long-term implications that involve hospitalization and death. In addition, when you strip PCR testing away from the laboratory, you might lose your blood testing too.
Engage early with the payer. Before you collapse your test, ask the payer if they’re willing to negotiate. For example, can you ask for a carve-out so you can still supply the test to a subset of your population? That process can be intense — which is why labs sometimes bring in industry consultants to help. You don’t have to be in-network to navigate a carve-out.
Longer term, you’ll need to come up with two things: clinical utility data and a CPT coding plan. Underneath a single CPT code, there are pathways forward to do that. Individual labs, if they want to continue with certain testing, either have to join a group that has clinical utility data or start producing such data themselves.
It can be really challenging. Labs historically follow the American Medical Association (AMA), but the recently reinterpreted National Correct Coding Initiative policy goes exactly against the AMA. That means that AMA advocacy will need to occur at an industry-wide level.
Again, reach out to the payer. A lot of the policies are not publicly posted, but there may be internal auditing processes in place. Rather than asking about individual patients or claims, connect to the provider education teams to ask what they want at a big-picture level.
At the end of the day, it comes down to internal compliance and auditing at the lab. Pull 10 random samples off your accessioning line and request chart notes on them. Does the order match the requisition? Do the ICD codes? Does the patient presentation?
Then come back a week later: Were the results utilized? Did they change the patient’s treatment plan? You can track the data to find the outliers. You’re going to come across problems, and you’re going to need to educate your providers.
This is where that provider education piece comes in. Even though lab professionals don’t provide direct patient care, they need to make sure — to the best of their ability — that patients who should be sent for a culture are sent for a culture, and that patients who are justified for PCR can get sent for PCR.
That way, when you appeal, you should have analytical validity data to draw on. For example, it might show that a patient had a failed treatment plan after culture, or they were at high risk of urosepsis or septic shock.
Finally, be concise. The best appeals compress information. If you want to provide additional details or add citations, you can always put them in links or QR codes. But a payer should be able to grasp what they might have gotten wrong within 2 minutes. Make your argument succinct and persuasive.
Clinical validity refers to being able to prove that a test can detect what you say it can detect when a patient presents at a clinic. Clinical utility is about being able to ensure that what you detect can actually change patient outcomes.
There are a lot of screening tests that are not reimbursable and not commercialization-ready even though they absolutely can do what they say they can do. The reason is that they do not impact patient outcomes, whether in the form of giving people a better chance of survival or reducing their hospitalization time.
So, after you’ve established clinical validity, clinical utility is the next bar to clear. And it’s important to do so because payers only want to pay for things that change their patient outcomes.
Make investments in clinical utility data, CPT coding strategies, and banding together with others in the industry to approach the AMA, Centers for Medicare and Medicaid Services, or other relevant entities.
Also, ask providers to write letters stating how your test has impacted their patients. Anecdotal or not, written testimonials provide powerful evidence that your providers want specific tests. These provider champion letters — and patient champion letters if you can get them — will provide helpful leverage for your negotiations with payers. Also ask your providers to track data you can use. For instance, did patients’ urinary tract infections resolve following their PCR testing?
It's a lot to take on, but you need to start somewhere. It's really about planning: Which pieces can we take on this quarter, next quarter, and the quarter after that? Before you know it, you will have future-proofed your way to a long-term strategy.
Karen Blum is a freelance medical/science writer in Owings Mills, Maryland. +Email: [email protected].
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The opinions, statements, and expressions contained in this document are those of the author(s) and are not necessarily those of Thermo Fisher Scientific. The content is provided for informational purposes only and should not be construed as legal, reimbursement, coding, billing, or other professional advice. The information provided in this document does not constitute a guarantee of coverage or payment by any federal, state, or third-party payers. Thermo Fisher is not responsible for the use of this information when billing Medicare, Medicaid, or other third-party payers including billing and coding errors that may result in the denial of coverage, payment, or payment amounts. Users of this information are ultimately responsible for determining applicable coverage, coding, billing, and payment requirements for their own use and/or on behalf of the patients they serve.