Pathology/Lab Coding Alert

MAAAs focus cancer risk assessment.

Ever since the U.S. Preventive Services Task Force (USPSTF) assigned a grade of 'D' (recommending against screening) to prostate specific antigen (PSA)-based screening, prostate cancer testing protocols have been in flux.

Problem: The USPSTF states that "a substantial percentage of men who have asymptomatic cancer detected by PSA screening have a tumor that either will not progress or will progress so slowly that it would have remained asymptomatic for the man's lifetime." Another study indicated that up to 75 percent of prostate biopsies demonstrate no prostate cancer or low grade cancer, and clinicians order many of these unnecessary biopsies based on elevated PSA.

Solution: Several new non-invasive prognostic and diagnostic assays that address various biomarkers have been developed in an effort to minimize unnecessary biopsies and the associated risks. Most of these tests are in the category of Multianalyte Assays with Algorithmic Analyses (MAAA) procedures.

Delve Into New Codes

CPT^® 2018 introduces three new codes for some of these tests, as follows:

• 81541 (Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a disease-specific mortality risk score)
• 81551 (Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy)
• 0021U (Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5'-UTR-BMI1, CEP 164, 3'-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score)

The first two codes describe testing that uses formalin-fixed paraffin-embedded prostate biopsy tissue as the specimen source.

Code 81541 describes Polaris^®, a commercially-available test that helps predict prostate cancer aggressiveness, and thus aid in clinical decision making for treatment and follow-up protocols.

"Polaris® is a prognostic test which directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients," according to John Warren, senior director of McDermottPlus Consulting, representing 21st Century Coalition at the CMS 2017 annual laboratory public meeting. "Polaris^® score is used to determine the aggressiveness of an individual patient's cancer. This risk score info is new and independent of standard clinical pathology features such as PSA or Gleason score," he says.

81551: This new code describes ConfirmMDx for Prostate Cancer. Using prior negative biopsy for the gene analysis, the "algorithm reports likelihood of prostate cancer detection on repeat biopsy," Warren says. This can directly address the "false negative biopsy" problem by either confirming that there is no cancer, or identifying cancer cells that the biopsy missed.

Code 0021U is a Proprietary Laboratory Analyses (PLA) code, meaning that the code describes only one unique lab test made by a specific manufacturer or performed by a specific lab. Code 0021U describes Apifiny^® by Armune Bioscience, Inc., which is an immunoassay and flow cytometry serum test for eight autoantibodies coupled with an algorithm to report a risk score for prostate cancer.

Recall 2017 code: These three new tests join another testing option that received a CPT^® Category I code last year: 81539 (Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 (hK2)), utilizing plasma or serum, prognostic algorithm reported as a probability score), which describes the 4Kscore^® test. The goal of this MAAA procedure is to point to aggressive prostate cancer while reducing unnecessary biopsies in men who have indolent low grade prostate cancer or no cancer at all. Specifically, the test attempts to predict a man's risk of having aggressive (Gleason score 7 or higher) prostate cancer on a biopsy if a biopsy were performed.

Background: "The Gleason score is the 'gold standard' for predicting the behavior of the prostate cancer - whether it will be indolent and slow-growing, or aggressive and spread more quickly," explains R.M. Stainton Jr., MD, president of Doctors Anatomic Pathology Services in Jonesboro, Ark. In other words, the Gleason score strongly informs the treatment decisions for the patient.

Coverage and Other Considerations

Many payers consider these newer MAAA tests for prostate cancer to be investigational. But that may be changing.

The National Comprehensive Cancer Network's (NCCN) 2017 Guidelines for Prostate Cancer Early Detection include the 4Kscore® and ConfirmMDx as recommended tests, in certain clinical circumstances.

The guidelines state, "It is well known that a negative prostate biopsy does not preclude a diagnosis of prostate cancer on subsequent biopsy. Those patients with negative prostate biopsies should be followed with DRE [digital rectal exam] and PSA. Tests that improve specificity in the post-biopsy state - including 4Kscore, PHI, percent free PSA, PCA3, and ConfirmMDx - should be considered in patients thought to be higher risk despite a negative biopsy."

The guidelines also indicate that clinicians may order the 4Kscore® test prior to a first prostate biopsy to help define the probability of high grade cancer.

Coverage: Medicare and other payer reimbursement for these tests generally happen slowly, often starting with Medicare contractor Local Coverage Determinations (LCDs) and regional coverage decisions with commercial payers. If your lab is looking to run any of these tests, you should contact involved payers for information about coverage and reimbursement.