Representing Laboratory Test Ordered

ACLA Comment on Representing Laboratory Test Ordered

The American Clinical Laboratory Association (ACLA) comments pertain to the Interoperability Standards Advisory (ISA) addition of CPT codes. The ISA added CPT Proprietary Laboratory Analyses (PLA) Codes Representing Laboratory Test Ordered. The PLA codes are listed in Appendix O of the American Medical Association (AMA) 2023 Professional Codebook. The ISA added CPT codes which represent the entire pathology/laboratory code section, codes 80047 – 89398, including Multianalyte Assays with Algorithmic Analyses (MAAA) codes 81490-81599, and MAAA administrative codes (0002M-0013M), which are not PLA codes. ACLA comments pertain to the ISA addition of the CPT pathology/laboratory, including MAAA and administrative MAAA and PLA codes, as a Standard for Representing Laboratory Test Ordered.

ACLA reiterates its comment that CPT codes and Proprietary Laboratory Analysis codes should be removed as a Standard for Representing Laboratory Test Ordered.  We agree with comments made on 9-30-2022 by APHL that the reference to CPT is confusing, as the Laboratory Order Interface (LOI) Implementation Guide calls for orders for lab tests to use LOINC wherever possible.  It states: “LOINC shall be used as the standard vocabulary to identify the ordered test in OBR-4 (Universal Service Identifier) when an applicable LOINC code is available and provided by the laboratory. When no valid orderable LOINC code exists, the local code may be the only code sent.” (Emphasis added.) “Shall” is a modal verb equivalent to “required” or “must” per HL7 conformance guidance.  The inclusion of CPT as a standard may give the erroneous impression that they are coequal with LOINC for purposes of Representing Laboratory Test Ordered.

CPT codes are used commonly for billing, which should be a separate section under Laboratory to accommodate that administrative use case.  In contrast, it is exceedingly rare for CPT codes to be used to order tests, even if the AMA is “aware of at least one large academic health system that uses PLA codes in their ordering of lab tests.” One entity, or only a handful of entities, using CPT codes for ordering does not warrant introducing this novel standard for identifying an ordered test. 

We do not believe there is sufficient justification at this time to introduce a new vocabulary for Representing Laboratory Test Ordered, especially when it would be additional expense for EHR systems/providers/and laboratories, which have designed their interfaces to support LOINC for order codes, and LOINC codes are better suited for laboratory test orders. 

Request that PLA and MAAA codes be maintained

The American Medical Association (AMA) requests that CPT codes, specifically the Proprietary Laboratory Analyses (PLA), Multianalyte Assays with Algorithmic Analyses (MAAA), and MAAA administration M codes, be maintained as a terminology standard for Representing Laboratory Test Ordered as they are currently listed. We are aware of over a dozen academic medical centers that use CPT and PLA codes in their laboratory test menus and catalogs. Our understanding of the general lab ordering process is that tests are initially ordered using the facility’s assigned unique test identifier, which is in turn mapped to LOINC, CPT codes, PLA codes, or other codes. These codes provide additional intelligence about the test ordered for the lab’s internal processing system. PLA codes provide information on all analytical services required for the analysis (e.g., cell lysis, nucleic acid stabilization, extraction, digestion, amplification, hybridization, and detection). Several health systems have requested PLA codes for genetic tests they perform and find clinical value in using these codes. CPT and PLA codes provide relevant clinical information about the test ordered and are not just for billing purposes. We believe this use case should continue to be recognized in Representing Laboratory Test Ordered.

Clarification of CPT Terminology in ORC-16

References in the comments on the use of ORC-16 do not accurately reflect the use of that field.  We refer the reader to the HL7 implementation guides for laboratory orders clarifying that ORC-16 represents the reason for the order, not a code such as LOINC, SNOMED, or CPT-PLA.  Further guidance on how and when to communicate LOINC and/or CPT-PLA codes would be identified in that guide as well.

Retain listing the CPT code set for Representing Laboratory Test

The CPT Editorial Panel created the Proprietary Laboratory Analyses (PLA) codes in 2016 in direct response to the Protecting Access to Medicare Act (PAMA) of 2014. PAMA enabled the creation of codes for advanced diagnostic laboratory tests (ADLTs) and clinical diagnostic laboratory tests (CDLTs) that are cleared and approved by the Food and Drug Administration (FDA). PLA codes describe proprietary clinical laboratory analyses that can be provided either by a single (“sole source”) laboratory or licensed or marketed to multiple providing laboratories (e.g., cleared or approved by the FDA). Any clinical laboratory or manufacturer can request a PLA code to specifically identify their tests. The tests included in the PLA section must be commercially available in the U.S. Current uses of PLA codes include ordering, billing, and reporting for various purposes. PLA codes can be used for recognizing, tracking, and ordering of specific tests, not just billing. We are aware of at least one large academic health system that uses PLA codes in their ordering of lab tests. PLA codes are used in the health care system to order lab tests and those workflows should be supported in health IT systems.

In 2012, the CPT Editorial Panel effected a significant expansion of molecular pathology codes to accommodate cutting edge medical needs and provide the flexibility and specificity to address both current and future expansion. A new subsection was added to the CPT code set in 2015 for Multianalyte Assays with Algorithmic Analyses (MAAA) and other molecular pathology tests. MAAAs are procedures that incorporate multiple results derived from assays of various types in an algorithmic analysis to report a numeric score(s) or probability. MAAAs are typically unique to a single clinical laboratory or manufacturer, and the resulting risk score or other value in itself represents a new and distinct medical property that is of independent medical significant relative to the individual component test results in clinical context in which the assay is performed. The results of individual component procedure(s) that are inputs to the MAAAs may be provided on the associated laboratory report.

ACLA ISA comment re: ISA clarifications and AMA CPT code proposa

Please clarify the term “harmonization status”.  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory order or provider’s EHR system laboratory order?

Does “numerically or categorically” mean/refer to “quantitative or qualitative”?  If so, we suggest using the terms “quantitative or qualitative” to avoid confusion. (These terms were used in the 2022 ONC’s LOINC survey so also for consistency.)

Currently SNOMED CT codes are not used for ordering laboratory tests.  We suggest removing the 1st bullet entirely or move it the “Representing Test Performed” category which does address the laboratory results where SNOMED CT codes may be used. 

Also remove the 3rd bullet since SNOMED CT is not pertinent to laboratory orders.

We suggest you move the last bullet to the “Representing Test Performed” since it pertains to laboratory results.  It is confusing to have references to laboratory results (test performed) in the same category as the test ordered.

Re: AMA’s suggestion to use CPT codes for laboratory orders, we suggest that AMA first work with HL7 to determine if CPT codes are approved by HL7 for laboratory test orders and if yes, how messaged. This must be done in conjunction with the HL7 Orders & Observations Work Group for maintenance of the LOI guide.  There are several issues:

• ORC-16 suggested by AMA is the Order Control Code Reason, defined as: “This field contains the explanation (either in coded or text form) of the reason for the order event described by the order control code (HL7 Table 0119). Whereas an NTE after the order-specific segment (e.g., RXO, ORO, OBR) would provide a comment for that specific segment, the purpose of the order control code reason is only to expand on the reason for the order event.” 

OBX-16 field uses HL7 controlled vocabulary (HL7 Table 0119) and is NOT the code for the test ordered. Per HL7 rules, you cannot use CPT codes in this field.

• The LOI IG requires use of LOINC for order codes:

“LOINC shall be used as the standard vocabulary to identify the ordered test in OBR-4(Universal Service Identifier) when an applicable LOINC code is available and provided by the laboratory. When no valid orderable LOINC code exists, the local code may be the only code sent.”

“shall” is a modal verb equivalent to “required” or “must” per HL7 conformance

“local code” is used by laboratories, for example, pending assignment of a LOINC code by Regenstrief or identified by the IVD equipment manufacturer

• Currently the only mention of AMA in the HL7 LOI is “Following is a non-exhaustive list of third-party terminologies that may require a separate license:”
  • What is justification to introduce a new vocabulary, which would be additional expense for EHR systems/providers/and laboratories when there is already significant effort supporting LOINC for order codes, and LOINC codes are better suited for laboratory test order codes.
  • Typically, CPT codes are used by laboratories for billing/claims, not clinical laboratory test orders.  CPT typically indicates the procedure performed.  Multiple different tests are performed the same way, and therefore would have the same CPT code for multiple clinical laboratory tests.
  • CPT codes are too general for many laboratory clinical tests and might perpetuate many to one mapping issues as shown in CPT Code examples below:
    • CPT 80305 is drug screening by dipsticks, cups, cards or cartridges read visually
    • CPT 80306 is drug screening by dipsticks, cups, cards or cartridges read on an instrument reader
    • CPT 80307 is drug screening on a chemistry analyzer
    • Each code is only reported once per date of service regardless of the number of drugs tested
    • The codes include sample validation testing such as pH, specific gravity, nitrites, etc.

The AMA is requesting the…

The AMA is requesting the Current Procedural Terminology (CPT) code set be added to the standards listed in the Vocabulary/Code Set/Terminology Section: Representing Laboratory Tests. The implementation specification named in the Content/Structure Section of the ISA is the HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI) Release 1, STU Release 3 - US Realm, which defines the specifications and standards and provides implementation guidance for the electronic ordering of lab tests. Included in the LOI guide is the trigger event OML_O21 for sending the lab order and the ORC segment for Common Order. The CPT code set is a valid terminology for ORC.16 where the lab order code set is identified.

Based on the content standard of LOI supporting the use of the CPT code set for sending a lab order, we believe CPT should be included as an additional terminology for “Representing Laboratory Tests” in the Vocabulary/Code Set/Terminology Section. Since “the ISA should serve as the first resource consulted to inform the selection of standards and implementation specifications,” it would be reasonable for terminologies supported by a named content implementation specification be named in the ISA’s corresponding terminology interoperability need.