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.

AMA ISA comment re: ISA clarifications and AMA CPT code set

The AMA’s understanding of the Interoperability Standards Advisory is that it provides a catalogue of available standards that inform developers’ choices for meeting interoperability needs, and not just for EHR systems. We do not believe current implementations for representing laboratory orders should limit developers’ coding system options for new solutions. The ONC ISA Content/Structure section for Laboratory identifies HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI) Release 1, STU Release 3 - US Realm as the implementation specification for “Ordering Laboratory Tests for a Patient.” Within this implementation guide, OBR-4 (Universal Service Identifier) does include a note stating that LOINC is to be used to identify the ordered test. There are other areas in the implementation guide that open the potential for other coding systems, including:
  • Section 1.4.4 references LOINC and SNOMED CT as examples of vocabulary standards but does not limit the guide to their usage only.
  • Section 5.1 includes the data for common order (ORC). ORC.16 Order Control Reason Code includes ORC.16.3 Name of Coding System and it points to Table 0396 – Coding System. CPT is included in this table of coding systems.
  • Observation/Result (OBX) also includes Name of Coding System (OBX.3.3) with the same Table 0396.
Because CPT is a comprehensive and regularly curated uniform language that accurately describes medical, surgical, laboratory services, and diagnostic services, it should be included as a coding and terminology option for Representing Laboratory Tests Ordered. CPT has an extremely robust and mature development process with open and transparent meetings and clinical input from national medical specialties and relevant stakeholders. Again, the AMA’s understanding of the Interoperability Standards Advisory is that it provides a catalogue of available standards that inform developers’ choices for meeting interoperability needs, and not just for EHR systems. The inclusion of CPT is justified by the fact that implementations for representing laboratory orders should not limit developers’ coding system options for new solutions, but instead provide them a choice. CPT codes are used to represent lab test orders in the health care community. As such, developers should benefit from ONC's curation of available coding terminologies that reflects codes as they are used. Creating successful digital health products requires that developers are aware of the coding systems their customers use, have insight into available options and choices, and can leverage the ISA to help meet their customers' needs. CPT, as a comprehensive and regularly curated uniform language, is a viable terminology and coding option for developers to consider when developing solutions for representing laboratory orders interoperability needs.

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.