Letter of Medical Necessity
PCA3—Prostate Cancer Biomarker
A physician may want to include a letter of medical necessity with a preauthorization request, claim
submission, to facilitate the insurance review process for the benefit of the patient. Most major
insurance companies consider mutation testing medically necessary to establish a molecular
diagnosis of a disease when specific conditions are met;
1. The patient displays clinical features;
2. The result of the test will directly impact the treatment being delivered to the patient; and
We encourage health care providers to cover as many of the following points as possible that are
applicable to the patient:

Explanation that the mutation test has been ordered by a physician;

Explanation of the medical necessity for the test requested;

Treatment plan, including specific statements about the anticipated impact of the mutation
test on the patient’s medical management;

Patient's diagnosis and prognosis.
We remind you to read carefully through the entire letter of medical necessity to make sure it
makes sense for your patient.
<On Office Letterhead>
<Date>
<Insurance Company Name>
<Medical Director>, MD
<Address 1>
<Address 2>
<City>, <ST> <ZIP>
Re: <Patient Full Name>
Member ID: <Enter Member ID>
DOB: <MM/DD/YYYY>
Group ID: <Enter Group ID>
Dear Medical Director:
I am writing this letter on behalf of my patient, <Patient Name>, to request coverage for detection
of the Prostate Cancer Biomarker Gene 3 (PCA3). Prostate cancer is the second most common
cancer and second leading cause of cancer death in American men. Early detection traditionally
relies on digital rectal exam (DRE) and serum prostate specific (PSA) concentration, which have low
disease specificity. The majority of patients with elevated PSA have negative biopsies, potentially
due to prostate enlargement or benign prostatic hyperplasia (BPH). A more accurate test will aid in
the diagnosis and management of patients with indeterminate PSA (3-10 ng/mL) as well as
assessing the need for a repeat biopsy in patients with elevated total PSA and an initial negative
biopsy.
The PCA3 noncoding mRNA is a molecular biomarker used to aid in the diagnosis of prostate cancer.
PCA3 is highly over expressed in >95 percent of prostate cancer tissue with a median 66-fold upregulation compared with adjacent non-neoplastic prostatic tissue. PCA3 and PSA mRNAs are
quantified using the Hologic Progensa PCA3 assay. Immediately after performing an attentive DRE,
urine specimens are collected and transported in a urine-transport medium to stabilize the mRNA.
Magnetic beads coupled with target-specific oligonucleotides are utilized to purify the target
mRNAs (PCA3 and PSA) from urine. Transcription mediated amplification (TMA) amplifies PCA3
exons 3 and 4 and PSA exons 2 and 3. Amplicons are detected by a hybridization protection assay
using acridinium ester-labeled probes and quantified with a luminometer. The PCA3 score is
calculated as the ration of PCA3 mRNA copies to PSA mRNA copies. A PCA3 ≥25 correlates with a
high likelihood of prostate cancer on biopsy. A ≤24 correlate with a low likelihood of prostate
cancer on biopsy.
I am requesting this test for <Patient Name>. This letter documents the medical necessity of this
test to assist in the diagnosis of prostate cancer. Below is additional information about the patient’s
medical history and potential impact of the test resulted for the patient’s medical management.
Patient History and Diagnosis:
<Patient Name> is a <Age> -year-old <Gender > with a suspected diagnosis of prostate cancer
based on the following symptoms and clinical findings:
1. <Symptom/Diagnosis #1 with ICD-9 code>
2. <Symptom/Diagnosis #2 with ICD-9 code>
Family History: (if applicable)
<Patient Name> also has a family history, including:
<Family History>
Clinical Impression:
The patient’s symptoms and clinical history are suggestive of prostate cancer. PCA3 biomarker
testing will play an important role in making a diagnosis of prostate cancer and in guiding
appropriate medical management of the patient. An accurate diagnosis can assist the patient by:


Informed decision on initial or repeat biopsy of men with elevated or inconclusive PSA
and/or other risk factors.
Informed decisions about management and treatment (e.g., active surveillance,
prostatectomy, radiotherapy) by classifying disease in men with positive biopsies as
insignificant or aggressive
I recommend that you support this request for coverage of PCA3 Prostate Biomarker testing for
<Patient Name> through ARUP Laboratories test code 2010102, Federal Tax ID#87-0403206 /
NPI#:1376548271 with the following CPT code 81313. Please note that this test is performed for
clinical management in a laboratory that is CLIA approved for high complexity testing. Please feel
free to contact me at <Physician Phone> if you require additional information.
Sincerely,
<Signature>
<Print Name>
References
 Groskopf J, et al. APTIMA PCA3 molecular urine test: development of a method to aid in the
diagnosis of prostate cancer. Clin Chem 2006;52:1089–95.
 Marks LS, et al. PCA3 molecular urine assay for prostate cancer in men undergoing repeat
biopsy. Urology 2007;69:532–5.
 Shappell SB, et al. PCA3 urine mRNA testing for prostate carcinoma: patterns of use by
community urologists and assay performance in reference laboratory setting. Urology
2009;73:363–8.
 Chevli KK , et al. Urinary PCA3 as a predictor of prostate cancer in a cohort of 3,073 men
undergoing initial prostate biopsy. J Urol 2014;191:1743-8
 Gittelman M , et al. PROGENSA® PCA3 molecular urine test as a predictor of repeat prostate
biopsy outcome in men with previous negative biopsies: A prospective multicenter clinical
study. J Urol 2013;190:64-9