Proprietary Laboratory Analyses Challenge the Rules
Key Takeaways
CPT 2026 significantly tightens PLA code governance, clarifying who can request codes, how proprietary status is defined, and when tests qualify—or no longer qualify—for PLA designation.
PLA codes remain non-Category I by default, with no physician work component or guaranteed pricing, reinforcing ongoing reimbursement uncertainty and payer scrutiny.
Material test changes now clearly trigger new PLA code requirements, including updates to biomarkers, algorithms, performance claims, or test naming—raising compliance risk if changes aren’t tracked.
Operational vigilance is essential, as quarterly PLA updates, payer coverage variability, and patient financial exposure (ABNs, documentation, medical necessity) must be actively managed.
According to the CPT editorial committee’s presentation this year “Proprietary laboratory analyses (PLA) codes describe proprietary clinical laboratory analyses and can be either by a single (“sole-source, operated by the same entity including the same or different locations, owned and ) laboratory or licensed or marketed to multiple providing laboratories (e.g., cleared or approved by the Food and Drug Administration [FDA]).”
Some key updates were discussed at this year’s symposium that impact coding and reimbursement for these services. It is also notable that there were 79 new codes, 10 revisions, and 13 deletions for CPT 2026. A full list of the new codes for 2026 with long descriptors can be found here: cpt-pla-codes-long.pdf
There is no physician work component for these services. They are not considered Category 1 codes and, as such, typically have no pricing associated with them. The criteria for inclusion in CPT as a PLA code saw major updates /additions (in green/underlined) and a few deletions (strike through in red) as follows:
The test must be commercially available in the United States for use on human specimens and
The CLIA-certified or accredited clinical laboratory performing the PLA test, the manufacturer offering an FDA-approved, cleared, or classified in vitro diagnostic (IVD) that offers the service, must request the code.
The definition of the code set saw changes to the description: (Additions are underlined and deletions are in red with a strike through)
►Proprietary laboratory analyses (PLA) codes describe proprietary clinical laboratory analyses and can be either provided either by a single (“sole-source, ” operated by the same entity including the same or different locations, owned and operated by the same entity ) laboratory or licensed or marketed to multiple providing laboratories (e.g., cleared or approved by the Food and Drug Administration [FDA]). PLA codes do not have a physician work component.
This subsection includes advanced diagnostic laboratory tests (ADLTs) and clinical diagnostic laboratory tests (CDLTs), as defined under the Protecting Access to Medicare Act (PAMA) of 2014. These analyses may include a range of medical laboratory tests including, but not limited to, multianalyte assays with algorithmic analyses (MAAA) and genomic sequencing procedures (GSP). The descriptor nomenclature follows, where possible, existing code conventions (eg, MAAA, GSP). An algorithm-only analysis of existing test results without biomarker analysis is not eligible for a PLA code.
Unless specifically noted, e Even though the Proprietary Laboratory Analyses section of the code set is located at the end of the Pathology and Laboratory section of the code set, a PLA code does not fulfill Category I code criteria. PLA codes are not required to fulfill the Category I criteria. The standards for inclusion in the PLA section are:
The test must be commercially available in the United States for use on human specimens and
The CLIA-certified or accredited clinical laboratory performing the PLA test or the manufacturer offering an FDA-approved, cleared, or classified in vitro diagnostic (IVD) that offers the test must request the code. ◄
The guidance for the use of these codes was updated this year as follows:
►All PLA tests will have assigned codes in the PLA section of the code set. Any PLA coded test(s) that satisfies Category I criteria and has been accepted by the CPT Editorial Panel for Category 1 Code Status will be designated by the addition of the symbol ⇅” to the existing PLA code and will remain in the PLA receive a new CPT code number and be placed in the appropriate Pathology and Laboratory section of the code set.
The deletion of the existing PLA code will coincide with the effective date of the new Category I code. Once a PLA code changes to Category I in any other subsection, other than MAAA, of the Pathology and Laboratory section of the code set, it will no longer have proprietary status and will be deleted from Appendix O. ◄
If a proprietary test has already been accepted for a Category I code and a code has not been published, subsequent application for a PLA code will take precedence. The code will only be placed in the PLA section.
►A new PLA code is required whenever the existing PLA has been updated in a manner that materially alters the original code descriptor, clinical indications, performance claims, or result reporting. Examples of changes that may trigger the need for a new PLA code include :
a. ►Additional nucleic acid (DNA or RNA) and/or protein analysis(es) are added to or removed from current PLA test, or
b. The algorithm (if used) has been materially changed so that it has expanded beyond its original intent, and
c. The name of the PLA test has changed in association with changes in test performance or test characteristics.◄
The addition or modification of the therapeutic applications of the test requires the submission of a code change application, but it may not require a new code number.◄
A summary listing of additions, deletions, and revisions applicable to the CPT… CPT add-on codes are annotated… Resequenced codes that are not placed numerically…
►Duplicate proprietary laboratory analyses (PLA) tests are annotated by the )( symbol. PLA codes describe proprietary clinical laboratory analyses and can be either provided by a single (“sole-source”) laboratory or licensed or marketed to multiple providing laboratories (eg, cleared or approved by the Food and Drug Administration [FDA]). All codes that are included in the PLA section are also included in Appendix O, with the procedure’s proprietary name. In some instances, the descriptor language of PLA codes may be identical and the code may only be differentiated by the listed proprietary name in Appendix O. When more than one PLA test has an identical descriptor, the codes will be denoted by the )( symbol. Even though the Proprietary Laboratory Analyses section of the code set is located at the end of the Pathology and Laboratory section of the code set, a PLA code does not fulfill Category I code criteria. ◄
Unless specifically noted, even though the Proprietary Laboratory Analyses section of the code set is located at the end of the Pathology and Laboratory section of the code set, a PLA code does not fulfill Category I code criteria. A PLA code(s) that has Category I status is annotated by the ⇅ symbol
Readers may wonder why address these services in light of everything going on with CPT for 2026. These services are constantly evolving, are difficult to get reimbursed for, and the documentation for the test and the test results can be missing from the clinical record. Here are some tips for success when handling the coding and billing for these services.
Many of these tests provide cutting-edge results not otherwise available and serve a need in the management of patient care. Since these proprietary tests are priced and billed by the laboratory that developed them, the charges can be very high to the patient. Patients should be advised of possible out-of-pocket liability prior to the performance of these tests. An ABN would be a good tool for use here when coverage is unknown. Under CLIA, the practice ordering the test should never be providing billing services on behalf of the proprietary laboratory.
Practices are often approached by the providers of these tests and encouraged to add them to their toolbox for patient care without regard to coverage or what might be considered for medical necessity. One unique example was a proprietary laboratory providing comprehensive genetic testing for expectant mothers in a state that had a contract with a reference lab for state testing of a multitude of genetic ailments for a flat fee negotiated by Medicaid. The thousands of dollars billed for these services were summarily denied due to the existing contractual arrangement. Coders need to be aware of these kinds of issues prior to offering tests without protection for the patient and the practice.
If there are fees assigned by your local MAC for PLA testing, check for associated coverage decisions. Since most third party payers consider these experimental, a review of your payer mix (the top five payers you submit claims to by volume) and an investigation of their policies for these codes is imperative for managing coding, billing, and reimbursement. Maintain all answers in writing for use later with appeals.
If your practice is using PLA testing, be aware that these codes are updated quarterly, and maintenance of your code set must be monitored accordingly. Coders should be encouraged to check for a PLA code prior to using a generic CPT code in the quest for coding to the highest level of specificity. Lastly, documentation of the order, rational for the order, and the results must be in the clinical record for compliant coding and billing.
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