SUPERSEDED Local Coverage Determination (LCD)

Susceptibility Studies

L33755

Expand All | Collapse All

Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

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

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.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced 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. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

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

Proposed Process Information

Synopsis of Changes

Changes	Fields Changed
	N/A

Associated Information

Sources of Information

Bibliography

Open Meetings

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Contact for Comments on Proposed LCD

Coding Information

ICD-10-CM Codes that Support Medical Necessity

ICD-10-CM Codes that DO NOT Support Medical Necessity

Additional ICD-10 Information

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 Date	Revision History Number	Revision History Explanation	Reasons 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

Updated On	Effective Dates	Status
11/16/2023	10/01/2019 - 11/16/2023	Retired	View
10/02/2019	10/01/2019 - N/A	Superseded	You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

Read the LCD Disclaimer

Please review and accept the agreements in order to view Medicare Coverage documents, which may include licensed information and codes.

LICENSE FOR USE OF PHYSICIANS' CURRENT PROCEDURAL TERMINOLOGY, FOURTH EDITION ("CPT")

End User Point and Click Amendment:

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the American Medical Association (AMA).

You, your employees and agents are authorized to use CPT only as agreed upon with the AMA internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, AMA Plaza 330 N. Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Applications are available at the AMA Web site, http://www.ama-assn.org/go/cpt.

Applicable FARS\DFARS Restrictions Apply to Government Use.

AMA Disclaimer of Warranties and Liabilities.

CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

CMS Disclaimer

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT should be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled "I Accept".

LICENSE FOR USE OF CURRENT DENTAL TERMINOLOGY (CDT^TM)

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement.

If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen.

If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. As used herein, "you" and "your" refer to you and any organization on behalf of which you are acting.

Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association web site, http://www.ADA.org.
Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. U.S. Government Rights Provisions.
Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.
ADA DISCLAIMER OF WARRANTIES AND LIABILITIES. CDT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for software, including any CDT and other content contained therein, is with CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement.

The ADA is a third party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CDT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material covered by this license. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I Accept". If you do not agree to the terms and conditions, you may not access or use software. Instead you must click below on the button labeled "I Do Not Accept" and exit from this computer screen.

LICENSE FOR NATIONAL UNIFORM BILLING COMMITTEE (NUBC)

American Hospital Association Disclaimer

The American Hospital Association ("the AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Submit Feedback/Ask a Question

Susceptibility Studies

Document Note

Note History

Contractor Information

LCD Information

Document Information

Issue

CMS National Coverage Policy

Coverage Guidance

Proposed Process Information

Coding Information

Bill Type Codes

Revenue Codes

CPT/HCPCS Codes

Group 1

ICD-10-CM Codes that Support Medical Necessity

Group 1

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Additional ICD-10 Information

General Information

Revision History Information

Associated Documents

Keywords

Page Help for LCD - Susceptibility Studies (L33755)

Introduction

More information

Tracking Sheet

Printing a Document to PDF

Get email updates

CMS & HHS WEBSITES

HELPFUL LINKS

RSS FEEDS