Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

The .gov means it’s official.

Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.

The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

    CMS.gov Centers for Medicare & Medicaid Services CMS.gov Centers for Medicare & Medicaid Services opens in new window
    CMS.gov Centers for Medicare & Medicaid Services
    Centers for Medicare & Medicaid Services

    Main header

    • About Us
    • Newsroom
    • Data & Research
    MCD
    Medicare Coverage Database
    • Advanced Search
    • Indexes
    • Reports
    • Downloads
    • National Coverage
      • National Coverage Analyses (NCAs)
        • Open NCAs
        • Closed NCAs
      • Coding Analyses for Labs (CALs)
        • Closed CALs
      • National Coverage Determinations (NCDs)
        • NCDs Listed Alphabetically
        • NCDs by Chapter/Section
        • Lab NCDs
      • Meetings & Assessments
        • MEDCAC Meetings
        • Technology Assessments
      • Medicare Coverage Documents
        • CMS Solicitation of Public Comments.
        • Compendia
        • Expedited Process to Remove National Coverage Determinations
        • Guidance Documents
        • National Benefit Category Analyses
        • Potential National Coverage Determination (NCD) Topics
    • Local Coverage
      • Local Coverage Determinations (LCDs)
        • LCDs by Contractor
        • LCDs by State
        • LCDs Listed Alphabetically
      • Articles
        • Articles by Contractor
        • Articles by State
        • Articles Listed Alphabetically
      • Contacts
        • All Contacts Listed Alphabetically
        • Contacts for Part A - Medicare Administrative Contractor (MAC - Part A)
        • Contacts for Part B - Medicare Administrative Contractor (MAC - Part B)
        • Contacts for Durable Medical Equipment Medicare Administrative Contractor (DME MAC)
        • Contacts for Home Health & Hospice (HHH)
    • National Coverage
      • What's New Report
      • Annual Report
    • Local Coverage
      • What's New Report
      • LCD Status Report
      • Proposed LCD Status Report
      • LCD Last Updated Report
      • Article Status Report
      • SAD Exclusion List Report
    0
    • Help & Resources
    • Page Help opens in new window
    • Contact Us

    MCD

    Y Y

    License Agreements

    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.
    Back to Self-Administered Drug (SAD) Exclusion List Report

    SUPERSEDED Local Coverage Determination (LCD):
    MolDX: Genetic Testing for Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) (L36155)


    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.

    Superseded stamp
    Please Note: This document version is not currently in effect. There are more recent versions available in the Public Version(s) section, below.
    • 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 MAC01111 - MAC AJ - ECalifornia - Entire State
    Noridian Healthcare Solutions, LLC A and B MAC01112 - MAC BJ - ECalifornia - Northern
    Noridian Healthcare Solutions, LLC A and B MAC01182 - MAC BJ - ECalifornia - Southern
    Noridian Healthcare Solutions, LLC A and B MAC01211 - MAC AJ - EAmerican Samoa
    Guam
    Hawaii
    Northern Mariana Islands
    Noridian Healthcare Solutions, LLC A and B MAC01212 - MAC BJ - EAmerican Samoa
    Guam
    Hawaii
    Northern Mariana Islands
    Noridian Healthcare Solutions, LLC A and B MAC01311 - MAC AJ - ENevada
    Noridian Healthcare Solutions, LLC A and B MAC01312 - MAC BJ - ENevada
    Noridian Healthcare Solutions, LLC A and B MAC01911 - MAC AJ - EAmerican Samoa
    California - Entire State
    Guam
    Hawaii
    Nevada
    Northern Mariana Islands

    Expand/Collapse the browser section LCD Information

    Document Information

    Superseded stamp
    LCD ID
    L36155

    LCD Title
    MolDX: Genetic Testing for Hypercoagulability / Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR)

    Proposed LCD in Comment Period
    N/A

    Source Proposed LCD
    DL36155

    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 06/16/2016

    Revision Effective Date
    N/A

    Revision Ending Date
    N/A

    Retirement Date
    N/A

    Notice Period Start Date
    04/28/2016

    Notice Period End Date
    06/15/2016

    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.”

    Title XVIII of the Social Security Act, §1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.

    42 Code of Federal Regulations (CFR) §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
    CMS Internet Online Manual Pub. 100-02 (Medicare Benefit Policy Manual), Chapter 15, Section 80, “Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests”

    CMS Internet-Only Manuals, Publication 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, 60.1.2 Independent Laboratory Specimen Drawing, 60.2. Travel Allowance.

    CMS Internet Online Manual Pub. 100-04 (Medicare Claims Processing Manual), Chapter 23 (Section 10) “Reporting ICD Diagnosis and Procedure Codes”.
    Coverage Guidance
    Coverage Indications, Limitations, and/or Medical Necessity

    Indications

    This is a non-coverage policy for genetic testing for thrombophilia testing for the Factor V Leiden (FVL) variant in the F5 gene, the G20210G>A (G20210A) variant in the F2 gene, and the MTHFR gene which encodes the 5,10-methylenetetrahydrofolate reductase enzyme. Genetic testing for these genes for all risk factors, signs, symptoms, diseases, or conditions, including cardiovascular risk assessment, are non-covered except for pregnant patients.

    Testing for FVL and F2 G20210A mutations is indicated for pregnant patients who have a history of personal VTE associated with a non-recurrent (transient) risk factor who are not otherwise receiving anticoagulant prophylaxis. The results of genetic testing can inform risk stratification for venous thromboembolism (VTE) recurrence and subsequent need for antenatal prophylaxis. However, Medicare will not add coverage of thrombophilia testing for pregnant women because they likely represent a very small group of potential Medicare (disabled) patients. Claims submitted on this limited Medicare population will deny per the policy, but should be appealed for coverage with submission of medical records supporting the necessity for testing, and specify how testing changed anticoagulant prophylaxis management for the patient.

    Background

    Thrombophilia (or hypercoagulability) is the propensity to develop thrombosis due to either an acquired or inherited defect in the coagulation system. The major clinical manifestation of thrombophilia is VTE. Acquired thrombophilia risk factors include but are not limited to advancing age (> 50), trauma, malignancy, chemotherapy, major surgery, immobilization, pregnancy, estrogen, inflammation, antiphospholipid antibody syndrome, myeloproliferative disorders, heparin-induced thrombocytopenia, liver disease, nephrotic and prolonged air travel. Inherited thrombophilia risk factors include deficiencies in antithrombin, Protein C, Protein S, mutations in FVL and F2, and dysfibrinogenemias. Mixed or unknown risk factors include hyperhomocysteinemia, elevated levels of Factor VIII, acquired Protein C resistance in the absence of Factor V Leiden, and elevated levels of Factors IX and XI.

    Testing for thrombophilia may consist of functional testing, antigenic testing, and genetic testing. Functional testing for thrombophilia may include tests such as:
    • Anti-phospholipid antibody (lupus anticoagulant);

    • Protein C;

    • Protein S;

    • Activated Protein C resistance (a surrogate for Factor V Leiden mutation);

    • Factor VIII

    • Fibrinogen

    • C-reactive protein

    • Homocysteine levels

    Antigenic testing may be performed to identify specific glycoprotein antibodies associated with abnormal functional anti-phospholipid antibody studies, or to subtype deficiencies detected by decreased Protein S, Protein C and Antithrombin functional activity.

    VTE is characteristically seen in deficiencies in Protein C, Protein S and antithrombin, as well as with FVL and F2 mutations. This is unlike the combination of arterial and venous thrombosis associated with hyperhomocysteinemia and lupus anticoagulant.

    Genetic Testing for Thrombophilia

    Genetic testing is available for a number of types of inherited thrombophilia, including mutations in the FVL, F2 and MTHFR genes. However, the clinical utility of testing is uncertain. The clinical utility of genetic testing depends on the ability of testing results to change management that results in improved clinical outcomes. The clinical utility of genetic testing for thrombophilia is based on the overall risk of thromboembolism and the risk/benefit ratio of treatment, primarily with anticoagulants.

    During the previous 5 years, a number of guidelines and/or position statements on testing for thrombophilia have been published. In 2011, The Evaluation of Genomic Applications in Practice and Prevention Working Groups (EGAPP) addressed genetic testing for FVL and F2 mutations. The expert consensus recommended:
    • There is no evidence that knowledge of FVL/F2 mutation status in patients with VTE affects anticoagulation treatment to avoid recurrence;

    • There is convincing evidence that anticoagulation beyond three months reduces recurrence of VTE, regardless of mutation status;

    • There is no evidence that knowledge of FVL/F2 mutation status among symptomatic family members of patients with VTE leads to anticoagulation aimed at avoiding initial episodes of VTE (See note).

    Note: The Medicare benefit applies only to individuals with signs and symptoms of disease. There is no Medicare benefit for assessment of thrombosis risk in asymptomatic patients (aka screening for inherited thrombophilia) or in asymptomatic individuals whose relatives have documented inherited thrombophilia.

    In 2008, the American College of Chest Physician’s (ACCP) published guidelines for the treatment of thromboembolic disease stated the following concerning genetic testing for thrombophilia:
    • The presence of hereditary thrombophilia has not been used as a major factor to guide duration of anticoagulation for VTE in these guidelines because evidence from prospective studies suggests that these factors are not major determinates of the risk of recurrence.

    In the 2012 ACCP Clinical Practice Guidelines, Guyatt et al (2012) and Bates et al (2012) make the following recommendations for treatment and management of VTE:
    • In persons with asymptomatic thrombophilia (i.e., without a previous history of VTE), we recommend against the long ­term daily use of mechanical or pharmacologic thromboprophylaxis to prevent VTE;

    • For pregnant women with no prior history of VTE who are known to be homozygous for factor V Leiden or the prothrombin 20210A mutation and have a positive family history for VTE, we suggest antepartum prophylaxis with prophylactic­ or intermediate ­dose low­ molecular­weight heparin (LMWH) and postpartum prophylaxis for 6 weeks with prophylactic­ or intermediate­ dose LMWH or vitamin K antagonists (VKAs) targeted at INR 2.0 to 3.0 rather than no prophylaxis;

    • For all pregnant women with prior VTE, we suggest postpartum prophylaxis for 6 weeks with prophylactic­ or intermediate­ dose LMWH or VKAs targeted at INR 2.0 to 3.0 rather than no prophylaxis;

    • For pregnant women at low risk of recurrent VTE (single episode of VTE associated with a transient risk factor not related to pregnancy or use of estrogen), we suggest clinical vigilance antepartum rather than antepartum prophylaxis;

    • For pregnant women at moderate to high risk of recurrent VTE (single unprovoked VTE, pregnancy­ or estrogen ­related VTE, or multiple prior unprovoked VTE not receiving long­ term anticoagulation), we suggest antepartum prophylaxis with
      prophylactic­ or intermediate­ dose LMWH rather than clinical vigilance or routine care.

    In the 2013 American Congress of Obstetricians and Gynecologists (ACOG) clinical management guidelines for inherited thrombophilia in pregnancy, ACOG experts note that the following guidelines are based on limited or inconsistent scientific evidence:
    • “Screening for thrombophilia is controversial. It is useful only when results will affect management decisions, and it is not useful in situations where treatment is indicated for other risk factors.

    • Screening may be considered in the following clinical settings:

      • A personal history of VTE that was associated with a non-recurrent risk factor (e.g., fractures, surgery, and prolonged immobilizations).

      • A first-degree relative (e.g., parent or sibling) with a history of high-risk thrombophilia.” (See note below)

    ACOG also stated that testing for inherited thrombophilia in women who have experienced recurrent fetal loss or placental abruption is not recommended because it is unclear if anticoagulation therapy reduces recurrence. They indicate that there is insufficient clinical evidence that antepartum prophylaxis with unfractionated heparin or low molecular weight heparin (LMWH) prevents recurrence in these patients, and note insufficient evidence to either screen for or treat women with inherited thrombophilia including complications such as fetal growth restriction or preeclampsia.

    On behalf of the American College of Medical Genetics (ACMG) (reaffirmed in 2006), Grody, et al (2001) recommended testing for FVL for the following indications:
    • Age under 50, any venous thrombosis;

    • Venous thrombosis in unusual sites (such as hepatic, mesenteric, and cerebral veins;

    • Recurrent venous thrombosis;

    • Venous thrombosis and a strong family history of thrombotic disease;

    • Venous thrombosis in pregnant women or women taking oral contraceptives;

    • Relatives of individuals with venous thrombosis under age 50;

    • Myocardial infarction in female smokers under age 50.

    ACMG suggested that FVL testing may also be considered in the following situations:
    • Venous thrombosis, age over 50, except when active malignancy is present;

    • Relatives of individuals known to have FVL. Knowledge that they have the FVL mutation may influence management of pregnancy and may be a factor in decision ­making regarding oral contraceptive use;

    • Women with recurrent pregnancy loss or unexplained severe preeclampsia, placental abruption, intrauterine fetal growth retardation, or stillbirth. Knowledge of FVL carrier status may influence management of future pregnancies.

    FVL testing is not recommended for the following:
    • A general population screen;

    • A routine initial test during pregnancy or prior to the use of oral contraceptives, hormone replacement therapy (HRT) or selective estrogen receptor modulators (SERMs);

    • A prenatal or newborn test, or as a routine test in asymptomatic children;

    • A routine initial test in individuals with arterial thrombosis (testing may be considered, however, in selected young individuals [under age 50] with unexplained arterial thrombosis in the absence of other risk factors for atherosclerotic vascular disease).

    In 2013, (ACMG) published a practice guideline on the lack of evidence for MTHFR polymorphism testing. Among a number of recommendations, ACMG experts concluded:
    • MTHFR polymorphism genotyping should not be ordered as part of the clinical evaluation for thrombophilia or recurrent pregnancy loss;

    • MTHFR polymorphism genotyping should not be ordered for at-risk family members.

    Non-coverage Summary

    Genetic testing for inherited thrombophilias is controversial. While the association between FVL and F2 mutations and increased risk for VTE is apparent, the actual impact of this increased risk on clinical management is less certain. Older professional society guidelines recommend genetic testing for thrombophilia for a wide range of indications, while more recent consensus statements and recommendations suggest much more limited clinical utility of testing.

    The population for which genetic testing results have direct implications for treatment is pregnant women with a previous history of VTE associated with a transient risk factor (e.g., surgery, trauma). These women would typically not be treated with antepartum anticoagulant prophylaxis unless they were found to have a genotype associated with a high risk of VTE recurrence (FVL homozygosity, F2 G20210A homozygosity, or compound heterozygosity for FVL and F2 G20210A). Genetic testing for these patients is indicated.

    There may also be benefit to screening pregnant women with a family history of known thrombophilia, as those women found to have a high risk genotype would be offered antenatal prophylactic anticoagulant therapy even in the absence of a personal history of VTE. However, the Medicare benefit applies only to patients with signs and symptoms of disease and does not include screening in asymptomatic patients.

    Finally, despite many earlier publications suggesting a link between MTHFR polymorphisms and a risk for a wide spectrum of obstetric and cardiovascular complications, it is now accepted that MTHFR genotype alone is not associated with VTE. There is no clinical indication for MTHFR genotyping in any population.


    There is insufficient evidence in the published peer-reviewed scientific literature to support coverage for genetic testing for inherited thrombophilias outside the pregnant women as described above. Genetic testing for FVL and F2 G20210A is considered investigational for all other indications. However, Medicare may consider coverage for FVL and/or F2 genetic testing in unusual circumstances where testing will change clinical management of the patient. Denied claims can be appealed with supporting evidence of specific medical necessity. Only providers with evidence of formal training with board eligibility or certification in hematology/oncology, hematopathology or coagulation disorders at an accredited program satisfy reasonable and necessary criteria for these tests . There is broad consensus in the medical literature that MTHFR genotyping has no clinical utility in any clinical scenario. This testing is considered investigational and is NOT a Medicare benefit.


    Expand/Collapse the Coding Information section Coding Information

    Superseded stamp
    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.

    CODEDESCRIPTION
    0x TBD

    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.


    N/A

    CPT/HCPCS Codes


    ICD-10 Codes that Support Medical Necessity

    ICD-10 Codes that DO NOT Support Medical Necessity

    Expand/Collapse the General Information section General Information

    Superseded 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 upon request.

    This final LCD, effective 06/16/2016, combines JEA DL36133 into the JEB LCD so that both JEA and JEB contract numbers will have the same final MCD LCD number.
    Sources of Information and Basis for Decision
    References

    1. ACOG Practice Bulletin No. 138: Inherited thrombophilias in pregnancy. Obstet Gynecol. 2013;122:706-17.

    2. Baglin T, Gray E, Greaves M, et al. Clinical guidelines for testing for heritable thrombophilia. Br j Haematol 2010;149(2):209-20.

    3. Bates SM, Greer IA, Middeldrop S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy. In antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e691S-736S.

    4. Bauer KA, Lip GYH. Evaluation of the patient with established venous thrombosis. In: Leung LLK LS (Ed). Up-To-Date Online, 2011.

    5. Bradley LA, Palomaki GE, Bienstock J, et al. Can Factor V Leiden and 0prothrombin G20210A testing in women with recurrent pregnancy loss result in improved pregnancy outcomes?; results from a targeted evidence-based review. Genet Med. 2012;1491):39-50.

    6. Geerts WH, Bergqvist D, Pineo GF, et al. American College of Chest Physicians; Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest.2008;133:381S–453S.

    7. Grody WW, Griffin JH, Taylor AK, et al. American College of Medical Genetics Consensus Statement on Factor V Leiden Mutation Testing. Genet Med. 2001;3(2):139–148. (Reaffirmed 2006).

    8. Gohil R, Peck G, Sharma P. The genetics of venous thromboembolism. A meta-analysis involving approximately 120,000 cases and 180,000 controls. Thrmob Haemost. 2009;102(2):360-70.

    9. Grandone, E. Villani M, Tiscia GL, et al. Clinical pregnancies and live births in women approaching ART: a follow-up analysis of 157 women after thrombophilia screening. Thromb Res 2014;133(2):168-72.

    10. Guyatt GH, Akl EA, Crowther M, et al. American College of Chest Physicians Antithrombotic Therapy and Prevention of Thrombosis Panel. Executive Summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence­Based Clinical Practice Guidelines. Chest. 2012;141:7S–47S.

    11. Hickey SE, Curry CJ, Toriello HV. ACMG Practice Guideline: lack of evidence for MTHFR. Genet Med 2013;15:153-6.

    12. Kearon C, Julian JA, Kovacs MJ, et al. Influence of thrombophilia on risk of recurrent venous thromboembolism while on warfarin: results from a randomized trial. Blood 2008:112(12):4432-6.

    13. Lijfering WM, Brouwer JL, Veeger NJ, et al. Selective testing for thrombophilia in patients with first venous thrombosis: results from a retrospective family cohort study on absolute thrombotic risk for currently known thrombophilic defects in 2479 relatives. Blood. 2009;113(21)5314-22.


    Expand/Collapse the Revision History section Revision History Information

    N/A

    Expand/Collapse the Associated Documents section Associated Documents

    Attachments
    N/A
    Related Local Coverage Documents
    Article(s)
    A54893 - Response to Comments: MolDX: Genetic Testing for Hypercoagulability / Thrombophilia opens in new window
    LCD(s)
    DL36133 - (MCD Archive Site)
    DL36155 - (MCD Archive Site)
    Related National Coverage Documents
    N/A
    Public Version(s)
    Updated on 01/29/2020 with effective dates 11/01/2019 - N/A
    Updated on 12/18/2019 with effective dates 11/01/2019 - N/A
    Updated on 10/08/2019 with effective dates 11/01/2019 - N/A
    Updated on 04/13/2016 with effective dates 06/16/2016 - N/A

    Expand/Collapse the Keywords section Keywords

    • 81240
    • 81241
    • 81291
    • Hypercoagulability
    • Thrombophilia
    • Factor V Leiden
    • Factor II Prothrombin
    • MTHFR
    • genetic
    • MolDx
    • pregnant
    • thrombophilia
    • FVL
    • G20210A
    Read the LCD Disclaimer opens in new window
    Footer Links
    • Submit Feedback/Ask a Question
    98

    Get email updates

    Sign up to get the latest information about your choice of CMS topics in your inbox. Also, you can decide how often you want to get updates.

    CMS & HHS WEBSITES

    • Medicare.govopens in new window
    • MyMedicare.govopens in new window
    • Medicaid.govopens in new window
    • InsureKidsNow.govopens in new window
    • HealthCare.govopens in new window
    • HHS.govopens in new window

    HELPFUL LINKS

    • Acronyms
    • Archive
    • Contacts
    • Glossary
    • Privacy policy

    RSS FEEDS

    • Newsroom
    • Blog
    • Podcast
    U.S. Department of Health & Human Servicesopens in new window Centers for Medicare & Medicaid Servicesopens in new window

    A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services.

    7500 Security Boulevard, Baltimore, MD 21244

    opens in new window opens in new window opens in new window

    TOOLS

    • Web policiesopens in new window
    • Plain languageopens in new window
    • No Fear Actopens in new window
    • Freedom of Information Actopens in new window
    • Inspector Generalopens in new window