Pathology/Lab Coding Alert

More lab tests, fewer biopsies may be in your future.

With protocols for prostate cancer diagnosis in flux since the U.S. Preventive Services Task Force (USPSTF) recommended against prostate-specific antigen (PSA)-based screening for prostate cancer, new biomarker and genetic tests are rushing in to fill the void.

One of those test options has a new CPT^® code for 2017. “Formerly an administrative code in Appendix ‘O’ for Multianalyte Assays with Algorithmic Analysis (MAAA), 0010M grows up and becomes a ‘regular’ [category 1] CPT^® in 2017,” says Kelly C. Loya, CPC-I, CHC, CPhT, CRMA, managing director of Pinnacle Enterprise Risk Consulting Services (“PERCS”), a division of Pinnacle Healthcare Consulting.

As of Jan. 1, you should be reporting the test as 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).

The Problem With PSA

When physicians order free and/or total PSA (84153, Prostate specific antigen [PSA]; total and 84154, … free), elevated test results have historically resulted in 1 million prostate biopsies per year. Of those, 75 percent demonstrated no prostate cancer or low grade cancer, according to Mitch Steiner, MD, FACS, consultant to OPKO Health, in his comments at the 2016 Annual Laboratory Public Meeting on Clinical Diagnostic Laboratory Tests.

A non-invasive lab test that would better predict invasive cancer could possibly save many men the risk of an unnecessary biopsy procedure. That’s the goal of the test described by 81539, which is a proprietary test called 4Kscore^® manufactured by OPKO Health.

“The goal is to predict a man’s risk of having aggressive (Gleason score 7 or higher) prostate cancer on a biopsy if a biopsy were performed,” Steiner stated at the meeting. “The test has high accuracy, reduces unnecessary biopsies in men who have indolent low grade prostate cancer or no cancer at all, and it also has the ability to look at clinically meaningful outcomes, which is metastatic disease.”

Understand Gleason Score

When pathologists examine prostate biopsies, they “grade” the cancer by assigning a number from 1 to 5 depending on how abnormal the cells appear, with 5 being the most aggressive cancer.

Because prostate cancers typically demonstrate different areas that show different grades, the pathologist assigns two number grades, which make up the Gleason score when added together.

“The primary grade describes the grade that is most common throughout the tumor, which is generally more than half the pattern observed,” explains R.M. Stainton Jr., MD, president of Doctors Anatomic Pathology Services in Jonesboro, Ark. “The secondary grade describes the pattern that occurs with the next greatest frequency,” he says.

For instance: The pathologist might report the Gleason score as 3+4=7, or Gleason 7 (3+4), or combined Gleason 7, or Gleason 7/10. Because the score is the sum of two numbers 1-5, the lowest Gleason score would be 2, and the highest would be 10.

Why it matters: 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. In other words, the Gleason score strongly informs the treatment decisions for the patient.

Cancers with Gleason 7 are considered intermediate grade, while Gleason 8 to 10 cancers are generally high grade, poorly differentiated, aggressive tumors. That’s why the goal of prostate biopsy, or any other test intended to predict outcomes and indicate assertive treatment, is to identify prostate cancers of Gleason 7 or higher.

Coverage and Other Considerations

Many payers consider the 81539 test and other biomarker or genetic tests for prostate cancer to be investigational. But that may be changing.

The National Comprehensive Cancer Network (NCCN) included the 4Kscore^® as a recommended test in the 2015 and 2016 NCCN Guidelines for Prostate Cancer Early Detection.

The guidelines state that clinicians may order the test prior to a first prostate biopsy, or following a negative biopsy to help define the probability of high grade cancer, Steiner explained in his comments at the meeting. Specifically, the 4Kscore® test is “for men with an abnormal PSA or digital rectal exam (DRE)” who might otherwise be scheduled for a prostate biopsy, he stated.

Pathologists look ahead: If clinicians begin ordering a test such as 81539 in a manner that cuts down on prostate biopsies, that would be a good thing in terms of reduced risk for unnecessary invasive procedures. But pathologists will also want to weigh in on how clinicians apply the 4Kscore® test result, and get involved in working with clinicians on monitoring the need for biopsy in patients who don’t proceed straight to the biopsy.