CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nation’s largest health insurer. In some ways, UHC’s test registry resembles the Medicare MolDx program administered by Palmetto GBA. This unwelcome news comes at a time when labs are under intense clinical and financial pressure because of the COVID-19 pandemic.
IT WAS BAD NEWS FOR MANY CLINICAL LABORATORIES AND ANATOMIC PATHOLOGY GROUPS when, on July 16, UnitedHealthcare (UHC) published new guidelines that will require labs to use a new test-registry program in order for their claims to be paid.
UHC’s new Test-Registry Protocol will require every in-network laboratory and anatomic pathology group to register almost every type of test before claims can then be submitted to the health insurer for payment.
This policy was initially scheduled for implementation on Oct. 1, 2020. But because of disruptions caused by the COVID-19 pandemic, UnitedHealthcare announced that it would delay implementation of this new policy by three months, until Jan. 1, 2021.
Since UHC first issued statements about the program earlier this year, many clinical labs and anatomic pathology groups have voiced concerns about the administrative burdens required to comply with the program. Lab leaders have also spoken out about the potential for UHC’s new program to significantly change the existing system of lab billing and reimbursement in ways that permanently shrink the cash flow of many labs.
Lab managers and pathologists are also troubled by how UHC’s new program may affect patient care if claims for medically-necessary tests won’t be paid.
UnitedHealthcare’s Test Registry Protocol will shake up the status quo in laboratory test coding/billing for two reasons.
First, it is the nation’s largest health insurer, covering 48.9 million members. Second, if UHC succeeds in implementing this program, other major health insurers will be encouraged to develop similar test-registry requirements for their health plans. From this perspective, UHC’s new Test-Registry Protocol is a high-stakes gambit with the potential to radically transform how lab tests are coded, billed, and reimbursed.
Register Each Test Code
In its July 16 announcement, UHC said its new Test-Registry Protocol requires all in-network labs and anatomic pathology groups to register each individual test code they use before they can bill for those codes.
Once the codes are registered, UHC will decide if the labs and pathology groups can use the codes when submitting claims for tests and anatomic pathology (AP) services, according to a notice that UHC posted on its website.
If the basic description of UHC’s new test-registry program has a familiar ring, it is because it seems to contain many of the elements of the Medicare MolDx program first introduced by Medicare Administrative Contractor Palmetto GBA in 2012, and which are still required today for certain Medicare regions. (See TDRs, Nov. 7, 2011, and Nov. 28, 2011.)
End of Stacking Codes
One goal of the original MolDx program was intended to end the use of stacking codes for the ever-growing numbers of proprietary molecular and genetic tests that were flooding into the market at that time. Another goal was to allow Medicare carriers to understand what the test was intended to do and how it was useful in clinical care.
When MolDx launched in 2012, it used the Z-Code system developed by McKesson that has since become the DEX Z-Code Identifier system. Certain payers use this system to supplement non-specific CPT codes.
The DEX Z-Code Identifier uses a five-character alpha-numeric code for certain molecular diagnostic tests. UHC appears to be applying a similar systemto identify almost all clinical lab tests and AP services.
What caught the full attention of lab administrators and pathologists is that UHC went “all in” with this program. First, the test-registry program is comprehensive in that it applies to most UnitedHealthcare commercial, Medicare Advantage, and Community Plan networks.
Second, the program affects all tests, test panels, and AP services from in-network, freestanding (or independent) laboratories, UHC said. And, it affects most lab testing services from outpatient hospital laboratories, UHC added.
Was MolDx Worth Copying?
One interesting question is how the Medicare MolDx program may have influenced the way UnitedHealthcare assessed current practices in lab test coding, billing, and payment. The Medicare program has the challenge of understanding what biomarker each new proprietary test is measuring, whether it accurately measures that biomarker, and if the results produced by the test change—in positive ways—how the physician treats the patient.
These are the same challenges private health plans face when labs submit claims for new tests that lack adequate clinical studies and data to support their accuracy and clinical utility. Maybe the Medicare MolDx program, now in its eighth year of operation at Palmetto, pioneered a way for other payers to gauge the accuracy and utility of new lab tests.
At the moment, however, the biggest question for labs and pathology groups is whether UHC can administer its new Test-Registry Protocol in a timely and efficient manner. If not, there may be much chaos and financial disruption in how labs submit test claims and UHC settles those claims after Jan. 1.