L29319-LCD

Automated World Health

Local Coverage Determination (LCD) for Susceptibility Studies (L29319)

Contractor Information

Contractor Name First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29319

LCD Title Susceptibility Studies

Contractor's Determination Number 87181

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 09/15/2009

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section 190.12

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, Sections 10 – 10.2; & 50.5.1 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, Section 40

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

Transmittal 1606, Change Request 6213, dated October 2, 2008

Indications and Limitations of Coverage and/or Medical Necessity

Some microorganisms are resistant to certain antimicrobials. Susceptibility testing is often used to determine the likelihood that a particular drug treatment regimen will be effective in eliminating or inhibiting the growth of the infection. A culture of the infected area must be done to obtain the organism for identification and to allow susceptibility testing to be performed if warranted. Referred to by the type of body fluid or cells collected (such as: blood culture, urine culture, sputum culture, wound culture, etc.), the culture involves incubating a sample at body temperature in a nutrient-rich environment. This process promotes the replication of any microorganisms present in the sample. Samples from the skin, stool, or sputum will grow normal flora as well as pathogenic bacteria if they are present. Other body samples, such as blood and urine, are usually sterile; they will show little or no growth unless a pathogenic microorganism is present.

Susceptibility testing is performed by growing the pure bacterial isolate in the presence of varying concentrations of several antimicrobials and then examining the amount of growth to determine which antimicrobials at which concentrations inhibit the growth of the bacteria. Antimicrobial susceptibility testing methods are divided into types based on the principle applied in each system. They include diffusion, dilution, and diffusion & dilution. Results of the testing are reported as “susceptible” (likely, but not guaranteed to inhibit the pathogenic microorganism), “intermediate” (may be effective at a higher than normal concentration), and “resistant” (not effective at inhibiting the growth of the organism). If there is more than one pathogen, the laboratory will report results for each one. The test results should be used to guide antibiotic choice. The results of antimicrobial susceptibility testing should be combined with clinical information and experience when selecting the most appropriate antibiotic for the patient.

Indications

Bacterial and fungal cultures are used to define the microbial etiology of the infectious or suspected infectious process and provide a guide for appropriate therapy. Medicare will consider susceptibility studies medically reasonable and necessary when performed as a result of a positive bacterial culture, and/or less often, positive fungal culture.

Limitations

Medicare does not pay for routine screening tests. Susceptibility studies will not be covered if the culture studies do not identify an organism.

Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be medically appropriate but is considered screening and therefore not covered by Medicare. The U.S. Preventive Services Task Force has concluded that screening for asymptomatic bacteriuria outside of the narrow indication for pregnant women is generally not indicated. There are insufficient data to recommend screening in ambulatory elderly patients including those with diabetes. Testing may be clinically indicated on other grounds including likelihood of recurrence of potential adverse effects of antibiotics, but is considered screening in the absence of clinical or laboratory evidence of infection.

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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

87181 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; AGAR DILUTION METHOD, PER AGENT (EG, ANTIBIOTIC GRADIENT STRIP)

87184 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; DISK METHOD, PER PLATE (12 OR FEWER AGENTS)

87185 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; ENZYME DETECTION (EG, BETA LACTAMASE), PER ENZYME

87186 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; MICRODILUTION OR AGAR DILUTION (MINIMUM INHIBITORY CONCENTRATION [MIC] OR BREAKPOINT), EACH MULTI-ANTIMICROBIAL, PER PLATE

SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; MICRODILUTION OR AGAR DILUTION, MINIMUM 87187 LETHAL CONCENTRATION (MLC), EACH PLATE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY

PROCEDURE)

87188 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; MACROBROTH DILUTION METHOD, EACH AGENT

87190 SUSCEPTIBILITY STUDIES, ANTIMICROBIAL AGENT; MYCOBACTERIA, PROPORTION METHOD, EACH AGENT

ICD-9 Codes that Support Medical Necessity

001.0 - 009.3 opens in new window CHOLERA DUE TO VIBRIO CHOLERAE - DIARRHEA OF PRESUMED INFECTIOUS ORIGIN

010.00 - 018.96 opens in new window

020.0 - 027.9 opens in new window

PRIMARY TUBERCULOUS COMPLEX UNSPECIFIED EXAMINATION - UNSPECIFIED MILIARY TUBERCULOSIS TUBERCLE BACILLI NOT FOUND BY BACTERIOLOGICAL OR HISTOLOGICAL EXAMINATION BUT TUBERCULOSIS CONFIRMED BY OTHER METHODS (INOCULATION OF ANIMALS)

BUBONIC PLAGUE - UNSPECIFIED ZOONOTIC BACTERIAL DISEASE

030.0 - 041.9 opens in new window

090.0 - 099.9 opens in new window

LEPROMATOUS LEPROSY (TYPE L) - BACTERIAL INFECTION UNSPECIFIED IN CONDITIONS CLASSIFIED ELSEWHERE AND OF UNSPECIFIED SITE

EARLY CONGENITAL SYPHILIS SYMPTOMATIC - VENEREAL DISEASE UNSPECIFIED

100.0 - 104.9 opens n new window LEPTOSPIROSIS ICTEROHEMORRHAGICA - SPIROCHETAL INFECTION UNSPECIFIED

110.0 - 118 opens in new window DERMATOPHYTOSIS OF SCALP AND BEARD - OPPORTUNISTIC MYCOSES

136.8 OTHER SPECIFIED INFECTIOUS AND PARASITIC DISEASES

139.8 LATE EFFECTS OF OTHER AND UNSPECIFIED INFECTIOUS AND PARASITIC DISEASES

V09.80 - V09.81* opens in new window

INFECTION WITH MICROORGANISMS RESISTANT TO OTHER SPECIFIED DRUGS WITHOUT RESISTANCE TO MULTIPLE DRUGS - INFECTION WITH MICROORGANISMS RESISTANT TO OTHER SPECIFIED DRUGS WITH RESISTANCE TO MULTIPLE DRUGS

* According to the ICD-9-CM book, diagnosis codes V09.80 and V09.81 are secondary diagnosis codes and should not be billed as the primary diagnosis.

See the “Coding Guidelines” attachment at the bottom of this LCD for the website link to the list of covered ICD-9-CM codes in the “Covered Code List” of the “CMS Medicare National Coverage Determination (NCD) Coding Policy Manual, section 190.12 – Urine Culture, Bacterial” for CPT codes 87086, 87088, 87184 and 87186.

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation (e.g., office/progress notes, hospital notes, and/or procedure report) maintained by the ordering/referring physician must indicate the medical necessity for performing the test. Additionally, a copy of the test results should be maintained in the medical records.

If the provider of the service is other than the ordering/referring physician/nonphysician, that provider must maintain hard copy documentation of test results and interpretation, along with copies of the ordering/referring physician/nonphysician’s order for the studies. The physician must state the clinical indication/medical necessity for the study in his order for the test.

Documentation should support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

Chapin, K. & Musgnug, M. (2003). Direct susceptibility testing of positive blood cultures by using sensititre broth microdilution plates. Journal of Clinical Microbiology 41 (10): 4751-4754.

De Cueto, M., Ceballos, E., Martinez-Martinez, L., Perea, E., & Pascual, A. (2004). Use of positive blood cultures for direct identification and susceptibility testing with the Vitek 2 System. Journal of Clinical Microbiology 42 (8): 3734-3738.

Lab tests online. (2005). Susceptibility testing. Retrieved November 5, 2007, from http://labtestsonline.org/understanding/analytes/susceptibility/glance.html

Lalitha, M. (2007). Manual on antimicrobial susceptibility testing. Retrieved November 7, 2007, from http://www.ijmm.org/documents/antimicrobial.doc

Sachais, B. (2007). Antimicrobial susceptibility testing, what does it mean? University of Pennsylvania Medical Center Guidelines for Antibiotic Use. Retrieved November 7, 2007, from http://www.uphs.upenn.edu/bugdrug/antibiotic_manual /amt.html

Tenover, F. (2006). Mechanisms of antimicrobial resistance in bacteria. The American Journal of Medicine 119 (6) 1.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 10/01/2009

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2009 Revised Effective Date: 09/15/2009

LCR B2009-094

September 2009 Update

Explanation of Revision: Revised to delete the list of ICD-9-CM codes in the Coding Guidelines and to update the access instructions for the online list of covered ICD-9-CM codes. This revision is effective for claims processed on or after 09/15/2009 for dates of service on or after October 1, 2008 for Florida and March 2, 2009 for Puerto Rico and U.S. Virgin Islands.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29319) replaces LCD L26921 as the policy in notice. This document (L29319) is effective on 02/02/2009.

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

87181 descriptor was changed in Group 1

87184 descriptor was changed in Group 1 87185 descriptor was changed in Group 1 87186 descriptor was changed in Group 1 87187 descriptor was changed in Group 1 87188 descriptor was changed in Group 1 87190 descriptor was changed in Group 1

Reason for Change