Tuesday, October 4, 2022

It's a Tough World for Tests: NGS MAC LCD on Ovarian Biomarkers (Nothing Covered)

There are a number of biomarkers for detecting ovarian cancer or working up adnexal masses.

If you'd like to be prepared for a tough review picking apart your new diagnostic test, get hardened up by reading the NGS MAC article about ovarian cancer tests (A58112) and the LCD (L38371).  I just ran across these documents; they're from 2020.

My only point here, is when you enthusiastically bring your shiny new test and your one first publication in 40 patients to Medicare or another payer, you may get some pretty rough handling.  (Many startup labs don't foresee this.)

Summarizing the NGS MAC author:

  • "This is a non-coverage policy for all multi marker serum tests related to ovarian cancer testing."

Read the LCD and data review here:


Read the public comment article and the NGS rebuttals, here:



While not the only tests reviewed, two of them, Ova1 and OVERA come from Aspira Women's Health.  Both have been FDA cleared.


Nasdaq AWH



The same MAC has a more liberal policy for several biomarker tests, like 4KScore, which are used to guide management of an intermediate PSA like "4".  It was just updated to add EPI, MyProstateScore, and isoPSA.

The summary coverage for prostate is below.  "Coverage" decisions are obviously longer than non-coverage decisions; the latter are basically one word, "no."

Coverage Indications, Limitations, and/or Medical Necessity

One biomarker test, ordered by a physician or other qualified health care professional (i.e., NP, CNS, PA) is covered ONCE per year. For men >/ 45 years old receiving testing prior to potential biopsy, covered testing includes %fPSA, PHI, Select MDx, 4K Score or MyProstate score, in men >/ 50 covered testing additionally includes EPI and isoPSA in those men >/ 50 with a PSA > than 4ng/ml. Those men, who need a repeat biopsy in the setting of patients thought to be at higher risk despite a prior negative biopsy, covered testing includes %fPSA, PHI, 4K Score, PCA 3, Confirm Dx, MyProstate Score and isoPSA with confirmed * moderately elevated PSA (>3ng/ml and <10ng/ml; or PSA >/4ng/ml and < 10ng/ml in men > 75 years of age) with BOTH of the following... [high risk indication of cancer, or contraindication to biopsy anyway]