Local Coverage Determination (LCD)

Susceptibility Studies

L33755

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Contractor Information

LCD Information

Document Information

LCD ID
L33755
LCD Title
Susceptibility Studies
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2021 American Dental Association. All rights reserved.

Copyright © 2013 - 2022, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Susceptibility Studies. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Susceptibility Studies and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site. 

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 3, Section 190.12 Urine Culture, Bacterial
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 16 Laboratory Services
    • Chapter 23, Section 40 Clinical Diagnostic Laboratory Fee Schedule
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD 

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Federal Register References:

  • Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

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.

Covered 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. Susceptibility studies will be considered medically reasonable and necessary when performed as a result of a positive bacterial culture, and/or less often, positive fungal culture.

Limitations

Routine screening tests are not payable. Susceptibility studies will not be covered if the culture studies do not identify an organism. 

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Susceptibility Studies (A57176) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Susceptibility Studies (A57176) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number(s) – L29021, L29319, L29396

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.

Lalitha, M. (2007). Manual on antimicrobial susceptibility testing.

Sachais, B. (2007). Antimicrobial susceptibility testing, what does it mean? University of Pennsylvania Medical Center Guidelines for Antibiotic Use.

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

Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
10/01/2019 R7

Revision Number: 5
Publication: September 2019 Connection
LCR A/B2019-058

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. In addition, the Social Security Act, Code of Federal Regulations, and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Based on CR 11322/CR 11333 (Annual 2020 ICD-10-CM Update) the newly created Billing and Coding Article was revised. Descriptor revised for ICD-10-CM diagnosis codes B96.21, B96.22, and B96.23. The effective date of this revision is for dates of service on or after 10/01/19.

10/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Revisions Due To ICD-10-CM Code Changes
  • Other (Revisions based on CRs 10901, 11322, 11333)
10/01/2017 R6

01/18/2019: Based on a review of the LCD, grammatical and/or typographical errors were identified and corrected.

  • Typographical Error
10/01/2017 R5

 

Revision Number:  5

 

Based on CR 10153 (2018 ICD-10 Update) LCD was evaluated and impacts identified.  The new ICD-10-CM changes are effective for dates of service on or after 10/01/2017.

 

  • Revisions Due To ICD-10-CM Code Changes
05/12/2017 R4

Revision Number: 2 Publication: June 2017 Connection LCR A/B2017-023


Explanation of Revision: Based on CR 8776, the following verbiage was removed from the “CPT/HCPCS Codes” section of the LCD: “Per CR 8572, beginning in CY 2014, payment for most laboratory tests (except for molecular pathology tests) will be packaged under the OPPS, therefore the clinical laboratory tests listed below, for TOB 13X (outpatient hospital), are packaged in this setting.” The effective date of this revision is for claims processed on or after 05/12/2017, for dates of service on or after 01/01/2014.

  • Provider Education/Guidance
04/05/2017 R3 Revision Number: 2
Publication: April 2017 Connection
LCR A/B2017-016

Explanation of revision: This LCD was revised to add ICD-10 diagnosis codes Z16.10, Z16.11, Z16.12 and Z16.19 to the “ICD-10 Codes that Support Medical Necessity” section of the LCD for CPT codes 87181, 87184, 87185, 87186, 87187, 87188 and 87190. Additionally, clarifying language referencing the “CMS Medicare National Coverage Determination (NCD) Coding Policy Manual, section 190.12 – Urine Culture, Bacterial” was added in the “ICD-10 Codes that Support Medical Necessity” section in the LCD. The effective date of this revision is for claims processed on or after 04/05/2017, for dates of service on or after 10/01/2015.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R2 Revision Number: 1
Publication: November 2015 Connection
LCR A/B2015-027

Explanation of revision: This LCD was revised to add ICD-10 diagnosis code range B96.0 - B96.89 to the “ICD-10 Codes that Support Medical Necessity” section of the LCD. In addition, ICD-10 diagnosis code range M00.10 - M00.19 was removed from the “ICD-10 Codes that Support Medical Necessity” section of the LCD, and ICD-10 diagnosis code range M00.00 - M00.89 was added to the “ICD-10 Codes that Support Medical Necessity” section of the LCD. The effective date of this revision is for claims processed on or after 11/12/15, for dates of service on or after 10/01/15.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 03/04/2015 - The language and/or ICD-10-CM diagnoses were updated to be consistent with the current ICD-9-CM LCD’s language and coding.
  • Provider Education/Guidance

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Articles
A57176 - Billing and Coding: Susceptibility Studies
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
10/02/2019 10/01/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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