Molecular diagnostic testing, which includes Deoxyribonucleic Acid- (DNA) or Ribonucleic Acid- (RNA) based analysis, with or without amplification/quantification, provides sensitive, specific and timely (i.e. relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current policy will focus upon such techniques for the former category in which three basic nucleic acid assay platforms are utilized.

A standardized nucleic acid probe reacts directly with nucleic acids in the test sample. This format is termed a Nucleic Acid Test (NAT). If the test sample contains the organism of interest the reaction (e.g., hybridization) of these elements will create a detectable endpoint.

In the second case, test sample nucleic acid is detected following amplification. This format is termed a Nucleic Acid Amplification Test (NAAT). The NAAT format increases diagnostic sensitivity by decreasing the lower limit of detection. Several techniques are available to perform such amplification, but one example is the polymerase chain reaction in which logarithmic copies of baseline nucleic acid material can be replicated via cyclical reactions involving “primer” nucleic acid, enzymes and requisite heating/cooling parameters.

Finally, there may be a need for the above process to quantify rather than simply detect the presence of certain microorganisms. Examples include Human Immunodeficiency Virus (HIV), hepatitis C, and Cytomegalovirus (CMV) treatment, which can require such quantitative monitoring to determine if therapy is producing the intended reductions in circulating levels of virus.

Furthermore, other techniques (i.e., nucleic acid sequencing) are utilized to assay antiviral resistance signatures for HIV-1 and hepatitis C. Either genotypic or phenotypic analysis can allow therapy to be directed in response to such observed resistance markers.

There are many difference organisms whose clinical presentations can be grouped into several categories or clusters.

When services billed with codes 87480, 87510 and 87660 are performed using one specimen for a test kit regardless of the number of medically necessary tests, only bill one unit of service using code 87797.

For CPT code 87500, no more than three units of service may be coded (and reimbursed) for the same date of service. This reflects the fact that no more than three genetic variants (e.g., Van A, Van B and/or Van C) should be necessary for the molecular evaluation of Vancomycin-resistant Enterococcus.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Documentation Requirements

Provider News

04/2012, New Medicare Advantage infectious disease molecular diagnostic testing guidelines explained.

Medicare Benefit Policy Manual – Pub. 100-02, Chapter Fifteen-Covered Medical and Other Health Services.

Medicare National Coverage Determinations Manual – Pub. 100-03.

Correct Coding Initiative – Medicare Contractor Beneficiary and Provider Communications Manual – Pub. 100-09, Chapter 5.

Social Security Act (Title XVIII) Standard References, Sections:

• 1862(a)(1)(A) Medically Reasonable & Necessary.
• 1862(a)(1)(D) Investigational or Experimental

Covered Diagnosis Codes

Applicable to Codes 87471, 87476, 87532, 87798, 87799, and 87498.