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Library: Policy

317:30-5-20.2. Molecular diagnostic testing utilizing polymerase chain reaction for infectious diseases

Issued 9-14-20

(a) Definitions. The following words and terms, when used in this Section, shall have the following meaning, unless the context clearly indicates otherwise.

(1) "Polymerase Chain Reaction (PCR)" means a biochemical laboratory technique used to make thousands or even millions of copies of a segment of DNA.It is commonly used to amplify a small amount of specifically targeted DNA from among a mixture of DNA samples.It is also known as Nucleic Acid Amplification Test (NAAT).

(2) "Direct Probe Technique" means detection methods where nucleic acids are detected without initial amplification processing.

(3) "Amplified Probe Technique" means technique without quantification, a detection method in which the sensitivity of the assay is improved over direct probe techniques.

(4) "Probe with Quantification Technique" means methods used to report absolute or relative amounts of nucleic acid sequences in the original sample.

(b) Medical necessity.

(1) PCR testing for infectious diseases, following clinical guidelines such as those set forth by the Infectious Disease Society of America=s (IDSA) or other nationally recognized medical professional academy or society standards of care, may be compensable.

(2)For the full PCR guideline which includes medically necessity and prior authorization criteria, and a list of codes that require authorization, please refer to

(c) Documentation.

(1) The medical record must contain documentation that the testing is expected to influence treatment of the condition towards which the testing is directed.

(2) The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition that warrants the test(s).

(3) Examples of documentation requirements for the ordering provider include, but are not limited to, history and physical exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing results).

(4) Documentation requirements for the performing laboratory include, but are not limited to, lab accreditation, test requisition, test records, preliminary and final report, and quality control record.

(5) Documentation requirements for lab developed tests/protocols include diagnostic test/assay, lab manufacturer, names of comparable assays/services (if relevant), descriptions of assay, analytical validity evidence, clinical validity evidence, and clinical utility.

(6) Billing providers are required to code specificity; however, if an unlisted or not otherwise specified Current Procedural Terminology (CPT) code is used, the documentation must clearly identify the unique procedure performed.When multiple procedure codes are submitted (unique, unlisted, and/or not otherwise specified), the documentation supporting each code should be easily identifiable.If on review the billed code cannot be linked to the documentation, this service may be denied.

(7) When the documentation does not meet the criteria for the service rendered/requested or the documentation does not establish the medical necessity for the service, the service may be denied as not reasonable and necessary.

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