NEW YORK – As multigene panels become more prevalent, confusion over how best to order, code, and reimburse for those tests has ramped up.
Health technology company Concert Genetics is working to make that revenue cycle management process easier. The Nashville, Tennessee-based company has developed a new taxonomy tool to identify genetic tests to make it easier for labs to determine what codes to use for what tests. The tool also helps health insurers match their medical policies to genetic tests to determine how to best reimburse labs.
Starting with its Concert Coding Engine that launched in 2019, Concert's focus has been on standardizing reimbursement across the genetic testing industry. Labs that offer multigene test panels often struggle to know what codes are appropriate, while payors have been concerned that labs are stacking CPT codes to bill for these tests inappropriately.
While the American Medical Association, which develops CPT codes, released a new system in 2013 for coding genetic tests using tiers — where Tier 1 codes describe the analyte gauged by a test and Tier 2 codes describe the base pairs or exons analyzed — labs can still stack those codes in claims for multigene tests by describing different analytes and methods used.
This variability leads to inconsistency in payment and confusion for payors who don't understand exactly what they're reimbursing for, which can cause them to restrict payment. According to a Concert Genetics white paper published in 2019, "code variation provides justification for further restrictive methods, most notably prior authorization."
For providers, coding variability and the response to it from payors "contributes to review processes that are costly or impractical to embed within the provider workflow," Concert Genetics wrote. Having laboratories in charge of these prior authorizations and other administrative support can take the burden off providers. In the white paper, the firm wrote "they add incremental costs … that ultimately must be borne by the patient, health insurer, or employer."
Knowing all of this, Concert Genetics decided to take its internal database of 160,000 different genetic tests and make it available to outside customers. While the Coding Engine drew on the database to map tests to specific codes, the ID system matches tests not only with codes but with the appropriate medical policies from different payors.
Concert CEO Rob Metcalf said the company "realized that there are limitations to … standardizing," and that even standard systems weren't "specific enough to be able to always and consistently tie to the medical policy" of insurers. "We hadn't gone far enough," with the Coding Engine, he said.
The "all-around identification of these tests" can help labs and payors track tests and ensure clarity in coding, he added. Each test has a five-digit alphanumeric code, called a Genetic Testing Unit, that users can access behind a login page without having to pay royalties, unlike CPT codes. While the initial identification number was 26 characters, Metcalf noted that most healthcare systems couldn't process that many characters and five characters is easier for labs and providers to fit on a claim form.
However, users can't take the information off Concert's website without paying a fee. Metcalf said there is "a small subset of usages of the information that are not royalty-free," such as payors and labs implementing the info into their electronic systems.
While most laboratories have their own test identification systems, such as Invitae and GeneDx, Metcalf said there is "not a universally accepted, broad, and accessible test identification system out there," with specific labs using different standards to number each test.
The database is organized by a hierarchy that allows a user to see all the tests within a particular group, Metcalf said. He was careful to emphasize that Concert's identifiers aren't CPT codes, since many tests require multiple CPT codes. Instead, the information in the database links the genetic tests to appropriate CPT codes.
Even if a test is no longer available on the market, it retains its ID number to ensure they can be included in retrospective analytics and for other uses.
Labs often face administrative burdens when trying to get paid for a test, including the need for prior authorizations and the extra work of resubmitting claims if one is denied. It can be "expensive for them to get paid," Metcalf said. The test ID system clarifies what exactly is covered before the claim is submitted and can help labs save time and money by alleviating some of that administrative burden.
Another benefit Concert can provide is linking the tests with a payor's specific medical policy that lays out what exactly is covered and why, Metcalf said. The company can create explicit matching to the policy, although it's not universal and only applies to the specific health plans that Concert works with. Metcalf said, however, that matching tests to medical policies for all insurers is where the market "needs to go."
To automate the medical policy matching, the system turns medical policies, usually in the form of text documents, into machine-readable criteria and links the criteria to its list of genetic tests.
Last week, the company announced it had received a patent, US patent number 10,223,501B1, for its method for converting medical policies.
Reimbursement expert Bruce Quinn said that payors don't like paying for unlisted or broad codes, so Concert's taxonomy can offer them more insights into what's being paid for while being a central resource of consolidated information.
He noted that there's "nothing like this." While the National Institutes of Health maintains a genetic test registry and the Centers for Medicare and Medicaid Services has its MolDx program, both of those lists are incomplete or only apply to certain kinds of tests or payors.
The ID system is part of a broader strategy to "bring transparency and efficiency to a space that's really complex and costly" and provide guidance in an "area where there was not an effective standard around test identification," Metcalf said. The system is also a living organism in a sense, constantly being added to and refined as more tests become available and insurers update medical policies.
Concert offers a range of software services, such as a subscription for hospitals that allows them to set formularies for certain labs that they want to send orders and receive results from, Metcalf said.
He added that on the provider side, there's "not a common way of tracking what was ordered." Tracking the tests would allow health systems and providers to know what genes are on each test and how many patients are being tested for certain conditions.
Concert also provides some integration services for laboratories, implementing software into laboratory information management systems to automate test orders, Metcalf said.
Quinn said Concert's database is reliant on what systems are built around it and that its efficacy "depends on what it's plugged into and who else uses it. … It's going to be useful to the extent it's integrated into other uses and needs." He added that it could be useful for automated test ordering, coverage and contracting decisions for payors, and for organizing the preferred providers a health system wants to use.
One of Concert's partners, electronic payments solutions provider Zelis, uses Concert's data to help apply genetic edits to claims. Priscilla Alfaro, Zelis' chief medical officer and a former medical director at insurer Anthem, said that her firm works with payors on denied claims. If there are questions about what coding edits to apply, the claim is sent to Concert, which applies the appropriate edits to the codes so they can be resubmitted.
The benefit of partnering with Concert, Alfaro said, is having a credible expert that Zelis can rely on if there are questions about claims. Since analyzing codes and staying up to date on a rapidly evolving industry is "their day job," they have answers to any questions, she said.
Concert's taxonomy helps explain why certain things aren't allowed and is "applying consistent and … aligned policies across the industry," she added. The ID system ensures that labs doing similar tests for the same indication are coding and being reimbursed properly, she said. It "takes that ambiguity out of the game," allowing stakeholders to know what test is being provided without relying only on the CPT code applied.
Using the system also ensures laboratories know the price of a test up front and it's "no longer a guessing game for anybody involved," Alfaro said. The provider, laboratory, and payor all know what is being paid for and why, she said, while it eliminates some of the complexity of coding from the labs and can help eliminate unnecessary denials.
Removing that ambiguity and ensuring the revenue cycle management process goes smoothly each step of the way is the key for Concert's system and its continuing expansions. "The infrastructure that exists … is inadequate," Metcalf said. "What we're shooting for is ensuring the market makes better use of tests."