Increasing reimbursement for genetic and molecular testing is a little bit of an art. We spoke with Michael Astion, MD, PhD, medical director of regional laboratories at Seattle Children’s Hospital, and Darci Sternen, MS, CGC, a laboratory genetic counselor at Seattle Children’s, for their recommendations. Astion and Sternen are active members of Patient-centered Laboratory Utilization Guidance Services (PLUGS), a laboratory stewardship collaborative co-founded by Astion to improve laboratory test ordering, interpretation, and reimbursement.
What steps has your lab taken to support strong reimbursement for genetic and molecular testing?
Sternen: Around 2012, we developed a pre-authorization process to make sure we were setting our institution and our patients up for reimbursement success. When a provider wants to order a genetic test, they first submit a pre-authorization request rather than the test order. We have a laboratory genetic counselor team that reviews the request, assigns appropriate CPT codes, and then routes this through our insurance processing department to ask the insurance payer for pre-authorization before the test is performed. Then, when the test is actually ordered, we have the information documented in the system so our billing department can make sure the pre-authorization is attached.
In addition, another purpose of the pre-authorization is that if an insurer decides not to cover the test, the clinical team can inform the family, and they can make an educated decision about whether they want to proceed with testing.
Astion: Most PLUGS members have set up systems for maximizing the chance that pre-authorization will be approved for medically necessary tests. In fact, we have a whole set of tools for both patients (
www.schplugs.org/plugs-patient-toolkit) and laboratories (
www.schplugs.org/insurance-alignment) to overcome a pre-authorization denial. With some insurance companies, the patient has to drive the appeal, and in some cases, the lab can drive it, so you have to have tools for both. The big emphasis when we talk about getting paid, is that we’re talking about tests that are medically necessary.
What best practices does your lab follow to help ensure that you’re selecting the proper CPT codes?
Sternen: When we assess a test during the pre-authorization process, we look to see what that test entails and what methodology and genes are involved, then we go directly to the CPT code book to find a code that is appropriate for that test. For some, there are codes that are very specific to the test or the indication, like the
CFTR gene associated with cystic fibrosis. For others, such as larger gene panels where there’s not a specific code, we can assess if an “unlisted procedure” code is appropriate. If it’s a send-out test, we also refer to the reference lab’s website and compare the code they’re using against what we think is appropriate.
Astion: Most labs that have a staff member involved in billing and coding follow a standard set of rules to find the closest CPT code, which occasionally is a proprietary laboratory analyses (PLA) code, a subset of the CPT coding system that is associated with individual proprietary tests from specific manufacturers.
Where labs tend to face problems is with their own laboratory developed tests (LDTs). Let’s say an LDT is expensive or it has some proprietary elements, and the lab invested a lot of money into developing it. They have to decide if they want to crosswalk into the regular CPT coding system or get a proprietary lab code. There are advantages and disadvantages to each. Insurance systems are tuned currently to deny PLA codes because the majority do not have sufficient evidence to be put into clinical practice. The door for new, PLA-coded tests tends to be closed, and labs have to open it by showing a significant amount of evidence. Once they do that, the PLA code is advantageous, but sometimes that only happens after years of using the test without getting paid. With the regular CPT code, you might get paid a little less, but you’re getting paid.
What processes has your lab implemented to help ensure that your documentation meets payer policies?
Sternen: For genetic testing, in addition to the test name, CPT, and ICD-10 codes, we attach clinical documentation to the pre-authorization request. This documentation specifically includes the provider clinic note that supports the medical necessity of the test — not just the rationale for why they want to order the testing, but also how the test results might change care. The goal is to send one communication to the payer that has all the documentation they need to understand the utility of the test for that patient. When we receive a denial, we can appeal with additional information if needed, but we’ve worked very hard with our providers and partners to provide medical necessity templates so they can state that upfront rather than needing to submit a separate communication later.
How do you use appeals to get reimbursed if legitimate claims are denied?
Astion: There are two kinds of denials: the easy ones and the hard ones. For the easy ones, sometimes something is administratively missing, so it just has to be filled in. The two major forms submitted, the CMS-1500 and the UV40, both have electronic versions with a lot of fields, so you can have an inadvertent error in fields representing the lab, the healthcare facility, patient demographics, or the insurance plan. Those are relatively straightforward to correct.
The harder ones are when the insurance company says a test is not medically necessary, or that it’s experimental, investigational, and unproven. If they say it’s medically not necessary, it usually means they have a policy where if you met inclusion criteria, you would get coverage and the lab would be paid. In that case, what you try to do is look at the case and provide additional information to show that it meets criteria. In the case of experimental, investigational, and unproven, that’s difficult because it’s usually denied in all cases. It’s harder to appeal. You have to convince the payer to change their policy permanently or allow an exception for that case.
Sternen: Across the PLUGS network, we’ve also found that it’s very important to have the right people assisting with reviewing the pre-authorization and denials. The laboratory genetic counselors in our system can help support providers, especially the increasing number of non-genetics providers from neurology, pulmonology, and other specialties who order genetic testing these days. Our lab genetic counselor team can review the denial with them and see if there’s a way to strategize overcoming that. We have examples where our team caught that it was just a misunderstanding from the insurance payer; they were denying a different test, and we were able to provide clarification and additional strength for the medical necessity language.
As payers continue to adjust coverage policies, coding requirements, and prior authorization rules, what strategies is your lab using to adapt and maintain reimbursement levels?
Astion: Lab testing can be lucrative. Unfortunately, the profit motive can lead to overtesting and offering tests prematurely, before there is strong evidence for clinical use. Insurance companies face a significant amount of inadvertent waste and purposeful abuse and fraud. As PLUGS members, we try to make a trade with them. We help them identify waste, abuse, and fraud, which saves them money, and then we say, “Hey, does the help we provide fertilize the ground for having a guardrails policy instead of a strict policy?” The guardrails allow for a broader range of evidence-based practice, especially for individuals with severe diseases, such as metastatic cancer, multi-system autoimmune or infectious diseases, or rare inherited diseases. So sometimes we provide insurance companies with a policy that we think is a guardrails policy, or we send them edits to their policies, often comparing them to our own, which they often welcome.
The best example of this is the widespread adoption of the PLUGS exome/genome policy that covers 60-70 million lives in the United States. This policy has gotten broader coverage for exomes and genomes while blocking medically unnecessary exomes and genomes. What we try to do is align with the insurance company, not thoughtlessly advocate for testing.
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.
