Get ready for Z-codes as DEX genetic testing registry rolls out to commercial health plans

Palmetto GBA Chief Medical Officer will present at the upcoming Executive War College in New Orleans on how clinical laboratories billing for genetic testing should prepare for Z-codes

After multiple delays, UnitedHealthcare’s (UHC) business plan will soon require clinical laboratories to use Z codes when submitting claims for certain molecular diagnostic tests. Several private insurance companies, including UHC, already require the use of Z codes in their Medicare Advantage plans, but starting June 1, UHC will be the first to mandate the use of these codes in its commercial plans. Dr. Gabriel Bien-Willner, a molecular, anatomic and clinical pathologist who oversees the coding system and is Palmetto GBA’s chief medical officer, expects other private payers to follow.

Bien-Willner explained in an interview that a Z-code is a string of random characters, similar to a barcode, that identifies a specific service at a specific lab. Dark daily life. The code itself doesn’t have much value, he said. Their utility comes from the DEX Diagnostics Exchange registry, where the code defines a specific genetic test and everything associated with it: the laboratory that performs the test. Test for intended use. The analyte being measured.

The registry also contains qualitative information, such as, is this a good test? Is it reasonable and necessary? He said.

Bien-Willner will answer these questions and more at the upcoming annual meeting Executive War College of Diagnostics, Clinical Laboratory and Pathology Management Held in New Orleans April 30-May 1.

Palmetto GBA takes control

Palmetto’s involvement with Z-Codes dates back to 2011, when the company established the MolDX program on behalf of the Centers for Medicare and Medicaid Services (CMS). The purpose is to process Medicare claims involving genetic testing. This coding system was originally developed by McKesson and adopted by Palmetto as a more granular way to track test usage.

In 2017, McKesson merged its information technology business with Change Healthcare Holdings LLC to form Change Healthcare. Palmetto GBA acquired the Z code and DEX registry from Change in 2020.

In addition to administering MolDX, Palmetto is one of four area Medicare contractors that require the use of Z codes on genetic testing claims. Together, these contractors handle Medicare claims in 28 states.

Benefits of Z-code

Why do I need to use Z codes? Bien-Willner explained that the system solves several fundamental problems with molecular diagnostic testing.

Payers interact with labs through claims, he said.Claims usually have a CPT code [Current Procedural Technology code] This doesn’t really explain what was done or why.

Additionally, molecular diagnostic testing is primarily done through laboratory-developed tests (LDTs) rather than FDA-approved tests, he said. We don’t think LDT is an issue, but services are not standardized. Two services can be described similarly, or use the same CPT code. But they may have different intended uses, different levels of sophistication, different methods, qualities and content. So, how do payers know what they are paying for and whether there are benefits?

He said that when a CPT code is accompanied by a Z code, we can now know exactly which tests were performed, who performed them, who was authorized to perform them, which analytes were measured and whether they met the coverage standards set out in the policy.

He explained that the process of obtaining the code begins when a lab registers with the DEX system. They then submit information about the test. They describe the intended use, the analyte being measured, and the method. After they submit all the necessary information, we give the test a Z code.

Then, tests are conducted for technical evaluation. Bien-Willner describes it as a risk-based process in which complex tests, such as those employing next-generation sequencing or gene expression profiling, are subject to higher risk than less complex methods, such as polymerase chain reaction (PCR) testing. More review.

He said the assessment could be as simple as a spreadsheet asking which cancer types the lab tested for in the validation. On the other hand, we might want to see the entire verification summary document, he said.

business potential

Bien-Willner joined Palmetto GBA in 2018 and is primarily responsible for directing the MolDX project. But he quickly saw the potential use of Z-code and the DEX registry in business plans. It’s clear, he said, that this is a problem for all payers, not just Medicare.

Over time, he said, we improved these processes to make them more repeatable, scalable and efficient. Business plans can now authorize the DEX system (of which Z-code is a part) to better automate claims processing or pre-authorization.

In 2021, the company began providing coding systems for Medicare Advantage plans, with UHC being the first to join. He explained that it would be much easier to launch the program for Medicare Advantage because those plans have to follow the same policies as Medicare.

As for UHC’s business plan, the insurer initially planned to require Z codes on claims starting on August 1, 2023, before delaying that to October 1. Dark daily lifes sister publications dark report.

Then it was postponed to April 1 this year, and now it is postponed to June 1.

Implementation will happen gradually, Bien-Willner suggested. It would be difficult to take a completely different approach to handling claims. You have to turn on about 10 switches to get everything to work properly, and only one switch at a time.

‘For Palmetto GBA, the business plan represents a completely different area of ​​business, which I think will have a huge impact on the industry,’ he said. They have the same problem as Medicare. But with Medicare, we have to create automated solutions upfront because it’s more of a pay-for-purchase model where claims are paid first and then CMS pursues erroneous or fraudulent claims.

Business plans generally just think they can solve the problem manually, piece by piece, he said. This approach works well when only a few genes are tested. There are tens of thousands of tests now and it’s impossible to keep up.

They have some programs in place to try to control these things, but I don’t think they work very well.

Bien-Willner plans to speak about the Palmetto GBAs MolDX program, Z-code and related topics at three upcoming conferences 29th Annual Executive War College Meeting. Managers of clinical laboratories and pathology groups would be well advised to attend his presentation. Please visit here (or paste this URL into your browser: https://www.executivewarcollege.com/registration) to learn more and secure your spot in New Orleans.

Stephen Beale

relevant information:

Palmetto releases Z code to track molecular Dx utilization, gathering data not provided by CPT code

McKesson and Change Healthcare complete creation of new health information technology company

UnitedHealthcare Commercial: Reimbursement Policy Update Announcement: January 2024

UnitedHealthcare’s Z-code requirement for genetic testing claims affects labs and payers

UHC extends April 1 Z-code commercial implementation to June 1, 2024

UHC to delay implementation of genetic testing declaration Z code