(Medicare Claims Processing Manual)

RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.  Group Code Contractual Obligation (CO)  MSN 16.77  This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.)  340  Transcatheter Edge -to-Edge Repair (TEER) for Mitral Valve Regurgitation  (Rev.  10985; Issued:09-08-21, Effective:01-19- 21; Implementation:10 -08-21)   Transcatheter Edge- to-Edge Repair (TEER) of the mitral valve (previously named Transcatheter Mitral Valve Repair (TMVR)) is used in the treatment of mitral regurgitation (MR).  TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.   The most recent reconsideration of NCD 20.33 (TEER for Mitral Valve Regurgitation (previously named TMVR)) is effective for claims with dates of service on and after January 19, 2021.  It expands coverage of mitral valve TEER procedures for the treatment of functional MR and maintains coverage of TEER for the treatment of degenerative MR, through coverage with evidence development (CED) and with mandatory registry participation.  It also makes changes to the criteria for the heart team and hospital, and to the registry questions/criteria and the trial requirements and outcomes.  For more detailed information see Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.33.  For services furnished between August 7, 2014 and January 19, 2021, the CMS covered TMVR for MR when furnished under CED when the treatment was furnished for an FDA-approved indication with an FDA-approved device as follows: (1) Treatment of significant, symptomatic, degenerative MR when furnished according to an FDA-approved indication and all CMS coverage criteria are met, and, (2) TMVR for MR uses not expressly listed as FDA -approved indications but only within the context of an FDA-approved, randomized clinical trial that meets all CMS coverage criteria. TMVR was non-covered outside CED or for non-MR indications.   Historical Note: For claims processing instructions from August 7, 2014, through January 19, 2021, please see the following links:   Change request (CR) 9002, Transmittal (TN) 178, issued December 5, 2014, informed Medicare Administrative Contractors to pay for TMVR under CED and revised the NCD manual to add NCD 20.33: https://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/Downloads/R178NCD.pdf.   CR 9002, TR 3142, issued December 5, 2014, implemented the initial NCD for TMVR, effective August 7, 2014. TR 3241 rescinded and replaced TN 3142 on April 25, 2014:  https://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/Downloads/R3241CP.pdf .  ICD-10 Coding Updates: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10  340.1  Coding Requirements for Mitral Valve TEER Claims Furnished on or After August 7, 2014 (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21)   Current Procedural Terminology (CPT) Codes for Mitral Valve TEER Claims   CPT code 33418, Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis, effective January 1, 2015.   CPT code 33419, Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis (es) during same session, effective January 1, 2015. (List separately in addition to code for primary procedure).   0345T -  Transcatheter mitral valve repair percutaneous approach via the coronary sinus   ICD- 10 Procedure Code for Mitral Valve TEER Claims   02UG3JZ  Supplement mitral valve with synthetic substitute, percutaneous approach  02UG3JH  Supplemental mitral valve with synthetic substitute, transapical, percutaneous approach   ICD- 10 Diagnosis Codes for Mitral Valve TEER   I34.0  Nonrheumatic mitral (valve) insufficiency, or,  I34.1  Nonrheumatic mitral (valve) prolapse, and, Z00.6  Encounter for examination for normal comparison and control in clinical research program   340.2  Claims Processing Requirements for Mitral Valve TEER Services on Professional Claims   (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21)   Professional Claims Place of Service (POS) Codes for Mitral Valve TEER Claims   Effective for claims with dates of service on and after August 7, 2014, place of service (POS) code 21 shall be used for mitral valve TEER services. All other POS codes shall be denied.   The following messages shall be used when Medicare contractors deny mitral valve TEER claims for POS:   Claim Adjustment Reason Code (CARC) 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), i f present.   Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.)  Medicare Summary Notice (MSN) 21.25: This service was denied because Medicare only covers this service in certain settings.   Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones."   Professional Claims Modifiers for Mitral Valve TEER Claims   Effective for claims with dates of service on or after August 7, 2014, contractors shall pay claim lines for mitral valve TEERs billed with the most recent CPT codes 33418, 33419, and 0345T in a clinical trial when billed with modifier - Q0. Mitral valve TE ER claim lines in a clinical trial billed without modifier - Q0 shall be returned as unprocessable.   The following messages shall be used when Medicare contractors return mitral valve TEER claim lines in a clinical trial billed without modifier - Q0 as unprocessable:   CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.   N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have w eb access, you may contact the contractor to request a copy of the NCD.   Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.)   Professional Clinical Trial Diagnostic Coding for Mitral Valve TEER Claims   Effective for claims with dates of service on or after August 7, 2014 contractors shall pay claim lines for mitral valve TEERs billed with the most recent CPT codes 33418, 33419 and 0345T in a clinical trial when billed with the most recent ICD -10 diagnosi s codes ICD -10 I34.0 or I34.1 and secondary ICD -10 diagnosis code Z00.6. Mitral valve TEER claim lines in a clinical trial billed without ICD -10 diagnosis code I34.0 or I34.1 and secondary ICD -10 diagnosis code Z00.6 shall be denied.   The following messages shall be used when Medicare contractors deny mitral valve TEER claim lines in a clinical trial billed without secondary ICD -10 diagnosis code Z00.6:   CARC 50: These are non -covered services because this is not deemed a medical necessity by the payer.   RARC N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.)   MSN 15.20: The following policies [NCD 20.33]] were used when we made this decision   Spanish Version: MSN 15.20: Las siguientes polticas [NCD 20.33] fueron utilizadas cuando se tom esta decisin.   Mandatory National Clinical Trial (NCT) Number for Mitral Valve TEER Claims   Effective for claims with dates of service on or after August 7, 2014, contractors shall pay mitral valve TEER claim lines billed with the most recent CPT codes 33418, 33419, and 0345T in a clinical trial only when billed with an 8- digit national clinical trial (NCT) number. Contractors shall accept the numeric, 8 -digit NCT number preceded by the two alpha characters of CT when placed in Field 19 of paper Form CMS -1500, or when entered WITHOUT the CT prefix in the electronic 837P in Loop 2300 REF02 (REF 01=P4). NOTE : The CT prefix is required on a paper claim, but it is not required on an electronic claim. Mitral valve TEER claim lines in a clinical trial billed without an 8 - digit NCT number shall be returned as unprocessable.   The following messages shall be used when Medicare contractors return mitral valve TEER claim lines as unprocessable when billed without an 8- digit NCT number:   CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.)   RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services.   Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.)   340.3 - Claims Processing Requirements for Mitral Valve TEER Services on Inpatient Hospital Claims (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21)   Inpatient hospitals shall bill for mitral valve TEER on an 11X type of bill (TOB) effective for discharges on or after August 7, 2014. Refer to Section 69 of this chapter for further guidance on billing under CED.   In addition to the ICD -10 procedure and diagnosis codes mentioned above, inpatient hospital discharges for mitral valve TEER shall be covered when billed with the following clinical trial coding:   Secondary ICD -10 diagnosis code Z00.6   Condition Code 30   Value code D4 -  Clinical Trial Number Assigned by NLM/NIH with an 8- digit clinicaltrials.gov identifier number listed on the CMS website   Inpatient hospital discharges for mitral valve TEERs shall be denied when billed without the ICD -10 diagnosis, procedure codes and clinical trial coding mentioned above. Claims that do not include these required codes shall be rejected with the following messages:   CARC 50: These are non -covered services because this is not deemed a medical necessity by the payer.   RARC N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   Group Code: CO (Contractual Obligation) assigning financial liability to the provider   MSN 15.20: The following policies [NCD 20.33] were used when we made this decision   Spanish Version: MSN 15.20 -  Las siguientes polticas [NCD 20.33] fueron utilizadas cuando se tom esta decisin.