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    MCD

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    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 2020 American Medical Association. 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 contained in the following authorized materials of CMS 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 Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Applications are available at the AMA Web site, http://www.ama-assn.org/cpt.

    Applicable FARS\DFARS Restrictions Apply to Government Use. Please click here to see all U.S. Government Rights Provisions. opens in new window

    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. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. 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 no 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 (CDTTM)


    End User License Agreement:

    These materials contain Current Dental Terminology (CDTTM), copyright © 2020 American Dental Association (ADA). All rights reserved. CDT is a trademark of the ADA.

    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.

    1. 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.

    2. 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.

    3. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. Please click here to see all U.S. Government Rights Provisions. opens in new window

    4. 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.

    5. 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.

    6. 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.


    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 the software. Instead, you must click below on the button labeled "I Do Not Accept" and exit from this computer screen.

    RETIRED Local Coverage Determination (LCD):
    MolDX: HLA-B*15:02 Genetic Testing (L36149)


    Alert: Codes have moved from LCDs to Articles! Learn more opens in new window

    Select the Print Complete Record, Add to Basket or Email Record Buttons to print the record, to add it to your basket or to email the record.
    Printing Note:
    To print an entire document, use the Need a PDF Button or the Print Complete Record Button.
    Note: Documents with coding fields will include all codes in each group.

    To print only the current visible page contents, use the Print Button in the page header.

    Retired stamp
    Please Note: This is a Retired LCD.
    • Expand All All sections on the page are Expanded
    • Collapse All All sections on the page are Collapsed

    Expand/Collapse the Contractor Information section Contractor Information

    Contractor NameContract TypeContract NumberJurisdictionState(s)
    Noridian Healthcare Solutions, LLC A and B MAC02101 - MAC AJ - FAlaska
    Noridian Healthcare Solutions, LLC A and B MAC02102 - MAC BJ - FAlaska
    Noridian Healthcare Solutions, LLC A and B MAC02201 - MAC AJ - FIdaho
    Noridian Healthcare Solutions, LLC A and B MAC02202 - MAC BJ - FIdaho
    Noridian Healthcare Solutions, LLC A and B MAC02301 - MAC AJ - FOregon
    Noridian Healthcare Solutions, LLC A and B MAC02302 - MAC BJ - FOregon
    Noridian Healthcare Solutions, LLC A and B MAC02401 - MAC AJ - FWashington
    Noridian Healthcare Solutions, LLC A and B MAC02402 - MAC BJ - FWashington
    Noridian Healthcare Solutions, LLC A and B MAC03101 - MAC AJ - FArizona
    Noridian Healthcare Solutions, LLC A and B MAC03102 - MAC BJ - FArizona
    Noridian Healthcare Solutions, LLC A and B MAC03201 - MAC AJ - FMontana
    Noridian Healthcare Solutions, LLC A and B MAC03202 - MAC BJ - FMontana
    Noridian Healthcare Solutions, LLC A and B MAC03301 - MAC AJ - FNorth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03302 - MAC BJ - FNorth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03401 - MAC AJ - FSouth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03402 - MAC BJ - FSouth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03501 - MAC AJ - FUtah
    Noridian Healthcare Solutions, LLC A and B MAC03502 - MAC BJ - FUtah
    Noridian Healthcare Solutions, LLC A and B MAC03601 - MAC AJ - FWyoming
    Noridian Healthcare Solutions, LLC A and B MAC03602 - MAC BJ - FWyoming

    Expand/Collapse the browser section LCD Information

    Document Information

    Retired stamp
    LCD ID
    L36149

    LCD Title
    MolDX: HLA-B*15:02 Genetic Testing

    Proposed LCD in Comment Period
    N/A

    Source Proposed LCD
    DL36149

    AMA CPT / ADA CDT / AHA NUBC Copyright Statement
    CPT codes, descriptions and other data only are copyright 2020 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 © 2020 American Dental Association. All rights reserved.

    Copyright © 2013 - 2020, 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.

    Original Effective Date
    For services performed on or after 04/01/2016

    Revision Effective Date
    For services performed on or after 11/01/2019

    Revision Ending Date
    09/16/2020

    Retirement Date
    09/16/2020

    Notice Period Start Date
    02/11/2016

    Notice Period End Date
    03/31/2016

    CMS National Coverage Policy

    Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or services that “are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

    42 Code of Federal Regulations (CFR) §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
    Coverage Guidance
    Coverage Indications, Limitations, and/or Medical Necessity

    Indications and Limitations of Coverage

    This policy provides limited coverage for HLA-B*15:02 genotype testing when the following criteria are met:

    • Patient is of Asian and Oceanian ancestry; AND
    • Initial treatment with carbamazepine, phenytoin or fosphenytoin is planned


    Background

    In 2004, researchers reported individuals with the HLA-B*1502 had an increased risk to develop Stevens-Johnson syndrome (SIS) or toxic epidermal necrolysis (TEN) when exposed to carbamazepine2. SJS and TEN, considered two variants of a disease continuum, are severe, sometimes lethal diseases of the skin and mucous membranes. A third, intermediate condition is called SJS/TEN. The most serious cases result in separation of the epidermis from the dermis in large sheets, which can also lead to infection. Sloughing can also occur in the bronchial, gastrointestinal and ocular epithelia.

    Estimates indicate 10-15% of the population from China, Thailand, Malaysia, Indonesia, the Philippines, and Taiwan carry the HLA-B*1502 allele. South Asians, including Indians, appear to have an intermediate chance of having HLA-B*1502, averaging 2 to 4%, but it is higher in some subgroups. Oceanians also have an increased incidence of HLA-B *1502 serotype. The incidence of the HLA-B*1502 serotype in the European Caucasian population has been reported at less than 0.1% 1, in the African population as 0.2% and in the Native American and Hispanic populations as 0% 3.

    In 2007, the FDA issued a black box label warning for carbamazepine stating, “Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment.” More recent evidence has supported the FDA recommendations 4 and at least one study has demonstrated that prospective screening of HLA-B*1502 has reduced the incidence of SJS/TEN in a Chinese population 5.




    Summary of Evidence

    N/A



    Analysis of Evidence
    (Rationale for Determination)

    N/A


    Expand/Collapse the General Information section General Information

    Retired stamp
    Associated Information

    Documentation Requirements

    The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See “Coverage Indications, Limitations, and/or Medical Necessity") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

    Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the MAC or other Medicare auditor upon request.

    This final LCD, effective 04/01/2016, combines JFA DL36147 into the JFB LCD so that both JFA and JFB contract numbers will have the same final MCD LCD number.

    Sources of Information



      1. Aihara, M. Pharmacogenomics of cutaneous adverse drug reactions. J Dermatol. 2011;38:246-54. 
      2. Chen, P. et al.; Taiwan SJS Consortium. Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N. Engl. J. Med. 2011:364, 1126–1133. 
      3. Chung WH, Hung SI, Hong HS, et al. Medical genetics: a marker for Stevens–Johnson syndrome. Nature. 2004;428:486. 
      4. Miller JW. Of race, ethnicity, and rash: the genetics of antiepileptic drug-induced skin reactions. Epilepsy Curr. 2008 Sep-Oct;8(5):120-1.
      5. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol. 2013 Sep;149(9):1025-32.

     

    Bibliography
    1. Aihara, M. Pharmacogenomics of cutaneous adverse drug reactions. J Dermatol. 2011;38:246-54.
    2. Chen, P. et al.; Taiwan SJS Consortium. Carbamazepine-induced toxic effects and HLA-B*1502 screening in Taiwan. N. Engl. J. Med. 2011:364, 1126-1133.
    3. Chung WH, Hung SI, Hong HS, et al. Medical genetics: a marker for Stevens-Johnson syndrome. Nature. 2004;428:486.
    4. Miller JW. Of race, ethnicity, and rash: the genetics of antiepileptic drug-induced skin reactions. Epilepsy Curr. 2008 Sep-Oct;8(5):120-1.
    5. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol. 2013 Sep;149(9):1025-32.

    Expand/Collapse the Revision History section Revision History Information

    Revision History DateRevision History NumberRevision History ExplanationReason(s) for Change
    09/16/2020 R5

    This LCD is being retired because the information in this policy has been incorporated within the MolDX: Pharmacogenomics Testing L38337 LCD.
    • LCD Being Retired
    11/01/2019 R4

    The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.

    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 policy.
    • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
      )
    11/01/2019 R3

    11/01/2019: This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision.

    Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: MolDX: HLA-B*15:02 Genetic Testing A57468 article. Under Sources of Information references were moved to the Bibliography section. Punctuation and typographical errors were corrected throughout the article.

    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 policy.
    • Provider Education/Guidance
    11/01/2019 R2

    As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.  

    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 policy.
    • Revisions Due To Code Removal
    02/26/2018 R1

    05/23/2019: 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 policy.

    Added ICD-10 B20 to the list of payable diagnosis codes.
    • Creation of Uniform LCDs With Other MAC Jurisdiction
    • Revisions Due To ICD-10-CM Code Changes

    Expand/Collapse the Associated Documents section Associated Documents

    Attachments
    N/A
    Related Local Coverage Documents
    Article(s)
    A57468 - Billing and Coding: MolDX: HLA-B*15:02 Genetic Testing opens in new window
    A54875 - Response to Comments: MolDX: HLA-B*15:02 Genetic Testing opens in new window
    LCD(s)
    DL36147 - (MCD Archive Site)
    DL36149 - (MCD Archive Site)
    Related National Coverage Documents
    N/A
    Public Version(s)
    Updated on 09/16/2020 with effective dates 11/01/2019 - 09/16/2020
    Updated on 01/29/2020 with effective dates 11/01/2019 - N/A
    Updated on 12/04/2019 with effective dates 11/01/2019 - N/A
    Updated on 10/08/2019 with effective dates 11/01/2019 - N/A
    Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

    Expand/Collapse the Keywords section Keywords

    N/A
    Read the LCD Disclaimer opens in new window
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