Local Coverage Article

MolDX: Algorithm definition as a component of a laboratory test

A58674

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Article Information

General Information

Article ID
A58674
Article Title
MolDX: Algorithm definition as a component of a laboratory test
Article Type
Article
Original Effective Date
03/11/2021
Revision Effective Date
04/22/2021
Revision Ending Date
N/A
Retirement Date
N/A
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Article Guidance

Article Text

The aim of this article is to promote a shared understanding of the term "algorithm" within the context of a clinical laboratory test. The objective of this article is to communicate the attributes of an algorithm as defined by this contractor within the stated context. The presence or absence of an algorithm as part of a lab service may be relevant to understanding the components of that service for coding or valuation purposes.

An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:

  • It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;
  • The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;
  • The same or similar test result could not be obtained without the use of this process;
  • The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;
  • The process must:
    • Either be required for the analytical result, OR
    • If adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.

Examples:

  • A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.
  • A next generation sequencing (NGS) test that uses computation to identify variants in a sample is not considered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.
  • Calculations using only clinical information not derived from analytical services on biological samples are not considered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.
  • A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.

Coding Information

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

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Additional ICD-10 Information

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Bill Type Codes

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Revenue Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
04/22/2021 R1

Under Article Title changed title to read, “MolDX: Algorithm definition as a component of a laboratory test”. Under Article Text deleted the first sentence and added the verbiage, “The aim of this article is to promote a shared understanding of the term "algorithm" within the context of a clinical laboratory test. The objective of this article is to communicate the attributes of an algorithm as defined by this contractor within the stated context. The presence or absence of an algorithm as part of a lab service may be relevant to understanding the components of that service for coding or valuation purposes” and revised the second sentence to read, “An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met”.

Associated Documents

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Public Versions
Updated On Effective Dates Status
12/17/2021 04/22/2021 - N/A Currently in Effect You are here
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Keywords

  • Algorithm