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Prostate Specific Antigen Testing

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					LCD for Prostate Specific Antigen Testing (L26685)
                                          Contractor Information
Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
05102, 05202, 05302, 05402
Contractor Type
MAC - Part B



                                             LCD Information
LCD ID Number
L26685


LCD Title
Prostate Specific Antigen Testing


Contractor's Determination Number
PATH-529


AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2009 American Medical Association (or such other
date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental
Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is
copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights
reserved. Applicable FARS/DFARS apply.


CMS National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for
only those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any
claim, which lacks the necessary information to process the claim.




Oversight Region
Region I
Region X
Original Determination Effective Date
For services performed on or after 02/01/2008


Original Determination Ending Date



Revision Effective Date
For services performed on or after 08/01/2009


Revision Ending Date



Indications and Limitations of Coverage and/or Medical Necessity
Prostate Specific Antigen is an antigen isolated from prostatic tissue and produced in the epithelial cells lining
the acini and ducts of the prostate.
A limitation for use of PSA in screening or early detection of cancer has been false positive elevations of PSA
in BPH, prostatitis, and prostatic ischemia or infarction. Using current assay technology, "normal" PSA is said
to be < 2.0-4 ng/ml, and "cancer levels" are thought to be above 10 ng/ml. Attempts to relate cancer-related
PSA to prostate density using transrectal ultrasound, or to relate PSA to velocity of change with time have been
helpful but flawed. PSA in the serum forms complexes with various factors including alpha1-antichymotrpysin.
It has been shown that such PSA binding is significantly higher in carcinoma of the prostate than in benign
prostatic conditions. For this reason, studies of the ratio of free PSA to total PSA have been made in patients
with and without known prostate carcinoma. Where free PSA is 23-25%, there is good predictive value that the
patient does not have prostate cancer; i.e., the higher the ratio of free PSA, the lower the risk of cancer. Since
there is tendency to biopsy all prostates with PSA values above normal, using the "free" PSA to total PSA ratio
could reduce negative prostate biopsies by 21-35%; therefore, the test may be helpful in deciding whether a
biopsy should be done

Percentage of free PSA may be used as follows:
• a single cut off (ie. perform a biopsy for all patients at or below a cut off of 25 percent free PSA).
• a patient risk factor or independent predictor of prostate cancer (ie. base biopsy decisions on each patient’s
risk of cancer)
• approximately 20 percent of cancer is missed on the first biopsy so factors like African-American descent
with two or more affected first-degree relatives (e.g. father, brother) or percent free PSA will help determine
those men who may be advised to have a second biopsy.

Consistent with national Medicare policy, performance of a free PSA test by a laboratory in response to an
elevated physician-ordered PSA test, in the absence of a specific physician order for the free PSA test (reflex
testing), is not payable.

Percent "free" PSA is useful for the diagnosis of prostate cancer, when the total PSA is above normal and a
prostate biopsy has not been done within the previous few weeks.

Testing for percent free PSA is not indicated in following known prostate cancer or metastases, in staging
newly diagnosed prostate cancer, or to be used for basic screening for prostate disease.
                                           Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report
this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.
Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy
should be assumed to apply equally to all claims.



Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to
report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy
services reported under other Revenue Codes are equally subject to this coverage determination.
Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and
the policy should be assumed to apply equally to all Revenue Codes.




CPT/HCPCS Codes


 84154                                                PROSTATE SPECIFIC ANTIGEN (PSA); FREE



ICD-9 Codes that Support Medical Necessity


 185                                                  MALIGNANT NEOPLASM OF PROSTATE
 222.2                                                BENIGN NEOPLASM OF PROSTATE
 236.5                                                NEOPLASM OF UNCERTAIN BEHAVIOR OF
                                                      PROSTATE
 790.93                                               ELEVATED PROSTATE SPECIFIC ANTIGEN
                                                      [PSA]



Diagnoses that Support Medical Necessity



ICD-9 Codes that DO NOT Support Medical Necessity




ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity




                                             General Information
Documentation Requirements
A patient’s medical record should reflect the reason for percent free PSA testing. If the test is performed twice
or more in a 12 month period the clinicians notes should state the reason.


Appendices



Utilization Guidelines



Sources of Information and Basis for Decision
WPS has consolidated the existing LCDs for MAC Jurisdiction 5 according to the instructions provided by
CMS so that they are the same throughout the jurisdiction. In the vast majority of cases, one least restrictive
LCD was selected as the jurisdictional LCD. In some cases, appropriate revisions, such as combining sections
of LCDs that only addressed a portion of a general topic into a single, more complete document, were made to
improve the clinical appropriateness of the LCD while keeping with the least restrictive requirement.

In situations where one or more of the states in the jurisdiction does not have an LCD on a topic, then the
existing LCDs were reviewed and, based on the merits of the LCD, a decision was made to make the LCD
jurisdictional or to have no LCD on that topic with the approval of CMS.

Some revisions of the existing LCDs were necessary to remove references to the former contractor and to
update the Sources of Information and Basis for Decision. CPT, HCPCS and ICD-9 codes will be updated as
necessary.

According to the J5 MAC contract, the J5 consolidated LCDs are posted on the web site for the 45 day final
notification period prior to the policy implementation date. The MAC contractor is not required to utilize the
formal notice and comment revision process specified in Chapter 13 of the Program Integrity Manual (PIM)
until the consolidation process is final. However, WPS welcomes provider input regarding the J5 consolidated
LCDs. Based on the comments received, LCDs will be revised as necessary during the transition from the
existing to new contractor.

This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final
decision rests with the contractor, this policy was developed in consideration of the active LCDs maintained by
the preceding Medicare contractors for Jurisdiction 5.

Ablin, Richard J. M.D., Prostate Specific Antigen: A Prognostic Indicator of Prostate Pathophysiology,
http://cancer.med.upenn.edu/disease/prostate/screening/Ablin.html
Bangmar H, Rietbergen JB, Kranse R. The free-to-total prostate-specific antigen ratio improves the specificity
of prostate-specific antigen in screening for prostate cancer in a general population. J Urol 1997 June : 157(6):
12191-6
Catalona WJ, Partin AW, Shawin KM, et al. Use of percentage of free prostate-specific antigen to enhance
differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA
1998 May 20; 279(19): 1542-7
Catalona WM, Beiser JA, Smith DS. Serum free prostate-specific antigen and prostate-specific antigen density
measurements for predicting cancer in men with prior negative prostatic biopsies. J Urol 1997 Dec; 158(6)
2162-7
Catalong, WJ, et. al, 1995 Oct. 18, JAMQA 275(15): 1214-1220
Jung., Meyer A, ET. al, 1997, Sept. Int. J. Cancer, 74(6): 630-636
Oesterling JE, Cooper WH, Jacobsen SJ,et al. Influence of patient age on the serum PSA concentration. Urol
Clin North Am 20; 671 1993
Raventos, J, et. al., 1997, May 29. Int. J. Cancer, 71(5): 756-759
Reissigl, A, et. al, 1996 Dec. Urology 48(6A Wsuppl): 62-66
Reiter W, Stieber P, Schmeller N. Is free prostate-specific antigen helpful in the differential diagnosis of
benign hyperplasia and cancer of the prostate? Tumor Biol 1997; 18(2) 80-7
Ruckle HC, Klee GC, Oesterlig JE. Prostate-specific antigen: critical issues for the practicing physician. Mayo
Clin Proc 1994: 69:59-68
Stein A, Barak M, Mecz Y et al. Serum free/total prostatic-specific antigen in cancer patient’s treated with LH-
RH agonists. Eur Urol 1997; 32 (1): 64-8
Thompson, I.M., et al.; Prevalence of Prostate Cancer Among Men with Prostate-Specific Antigen Level <4.0
ng per Milliliter; NEJM, Vol 350, No 22, May 27, 2004



Advisory Committee Meeting Notes



Start Date of Comment Period



End Date of Comment Period



Start Date of Notice Period
12/15/2007


Revision History Number
1


Revision History Explanation
07/30/2009: Restored accidental removal of contract number 05392 (WPS Part B MAC Eastern Missouri),
effective 03/01/08. Correctly removed contract number 05392 effective 8/1/2009, as it is being combined with
contractor number 05302 (WPS Part B MAC Missouri - Entire State.)

Removed contractor number 05392 E MO. This number is being joined with W MO to include all of MO under
one contractor number effective 8/01/2009.

added Missouri Eastern


Reason for Change
Last Reviewed On Date
11/01/2007


Related Documents
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                                              All Versions
Updated on 07/30/2009 with effective dates 08/01/2009 - N/A
Updated on 07/30/2009 with effective dates 03/01/2008 - 07/31/2009
Updated on 07/17/2009 with effective dates 03/01/2008 - N/A
Updated on 05/23/2008 with effective dates 03/01/2008 - N/A
Updated on 03/28/2008 with effective dates 03/01/2008 - N/A
Updated on 03/07/2008 with effective dates 03/01/2008 - N/A
Updated on 12/07/2007 with effective dates 02/01/2008 - N/A

				
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