Transcatheter Valvular Procedure Code Set Updates

Transcatheter Valvular Procedure Code Set Updates:

New Technologies and the Codes You Should

Capture

Jayna Tuominen RHIA, CIRCC, CCC

Senior Healthcare Consultant

Meet Your Speakers

Panacea Healthcare Solutions

email: jtuominen@panaceainc.com

Director

Panacea Healthcare Solutions

email: bjacobsen@panaceainc.com

Becky Rodrian-Jacobsen, CCS-P, CPC, CPEDC,CBCS, MBS, CEMC, BSN

of Coding and Documentation

Jayna Tuominen, RHIA, CIRCC, CCC Senior Healthcare Consultant

PANACEA HEALTHCARE SOLUTIONS

A SOLUTION FOR ALL PROBLEMS AND A CURE FOR ALL ILLS

Established 2007 with offices in Minnesota and New Jersey, Panacea is led by a seasoned team of revenue cycle, clinical coding and financial consulting experts.

Our services and software are used by 500+ healthcare organizations, including hospitals, health systems, physician practices, ambulatory surgical centers and ancillary care providers.

Products & Services

We are experts in the entire continuum of healthcare pricing.

Software and Technology

We provide our software and technologyenabled services to a wide array of providers

Customized Solutions

We deliver our solutions in whole or in part to create a customized approach to meet our clients’ specific needs

We Help Your Organization Achieve:

• Accurate and complete charges and associated codes

• Strategic and defensible prices associated with each code

• Compliant price transparency and out - ofpocket estimates

• Integrity of coding and revenue

suscipiantur vim in, ne postea debitis eleifend ius.

• Compliance with all federal regulations

Introduction and Cardiac Anatomy

How Transcatheter Techniques are Reshaping Treatment Options

 Prior to the development of transcatheter valvular surgery, valve replacement and repair necessitated an open heart/sternotomy approach.

 Patients who were inoperable or too high risk for surgical valve procedures were treated palliatively.

 Transcatheter valve procedures allow a minimally invasive way to deliver a replacement valve or a valve repair option via an endovascular approach instead of via open heart surgery.

 Transcatheter valvuloplasty pioneered in the 1980s is the predecessor to transcatheter valve replacement and repair.

 The first successful human aortic valve replacement was a TAVR procedure performed in 2002.

 There are now roughly 23 CPT code options to capture transcatheter valvular procedures across all four cardiac valves.

Types of Prosthetic Heart Valves

 Mechanical Valves

 Bileaflet, Monoleaflet, Caged Ball Valves (these were the first)

 Pros: Better durability (Titanium, Carbon, Teflon) 30+ years, younger patients already on anticoagulants

 Cons: Require Warfarin, Some patients can hear an audible clicking, Replacement not always possible

 Bioprosthetic (Tissue) Valves: (i.e.. Bovine and Porcine)

 Stented and Stentless

 Percutaneous (transcatheter)

 Balloon Dilated

 Self-Expandable

 Pros: Transcatheter delivery (Minimally Invasive), No warfarin, Better for right sided valve disease in older population, Better for those very physically active

 Cons: Durability. Studies show failure after 10 years or even less in dialysis patients

Cardiac Anatomy- Four Chamber Plane

Pulmonary Artery

Pulmonary Vein

Pulmonary Valve

Cardiac Anatomy-Short-Axis Plane

Transcatheter Valve Procedures and Clinical Trials/Data Registry

Requirements

 Transcatheter valvular procedures are on the cutting edge of medical innovation and are rapidly expanding.

 Many of these procedures are subject to FDA approved clinical trials and data registries to test their safety/efficacy, advance their indications for use, and to see how they benefit different patient populations prospectively.

 Clinical Trials and Registries are given a National Clinical Trial Number (NCT) Number when registered with the National Library of Medicine.

 Some procedure types are required by CMS via NCDs to participate in an FDA approved clinical trial or in a nationally recognized data registry (or both) as a condition of payment.

 TAVR/TAVI (CPT 33361-33366)

 TMVr/TEER (CPT 33418, 33419)

 NCDs along with Chapter 32 sections 68 and 69 of the Medicare Claims Processing Manual outline how to successfully submit a claim and obtain proper reimbursement for a clinical trial procedure.

Successful Clinical Trial Information Capture

 Capturing all this necessary information necessitates a multidisciplinary team effort for successful claim submission and reimbursement-Create a Clinical Trial Coding and Billing Team.

 Implement open lines of communication and information sharing throughout entire revenue cycle process, so all players are aware of participation in a clinical trial and can do their part to contribute to the success of the effort.

Poll #1

Do you have solid lines of communication between your clinical staff and revenue cycle staff?

a. Yes b. No c. We are working on it

Successful Clinical Trial Information Capture

 At the onset of the enrollment process for your provider(s)/institution to participate in a clinical trial:

 Physician/Clinical Trial Department: Gather the entire team to make them aware of the potential new clinical trial enrollment.

 Once enrollment is approved by the clinical study IRB:

 Clinical Trial Department: Supply the team with the following information:

 (National Clinical Trial) NCT number

 Copy of CMS approval letter

 FDA IDE number for investigational device, if applicable (starts with a G)

 FDA IDE Category (Either A or B)

 A = experimental/investigational

 B = nonexperimental/noninvestigational

 The names and NPIs of each provider enrolled as a principal investigator

Successful Clinical Trial Information Capture

 Coding (Profee and Facility):

 Begin researching the CPT code(s) ICD-10-CM, and PCS codes associated with the clinical trial

 Review for possible NCDs, NCAs, and LCDs or other coverage documents.

 Remember to apply modifier Q0/Q1 to CPT codes when applicable

 Q0 = Procedure under investigation Q1 = All other routine services

 Be aware of any required diagnosis codes necessary to be submitted on the claim (i.e.. Z00.6-Encounter for examination for normal comparison and control in clinical research program.

 CDM/Revenue Integrity:

 Execute necessary CDM builds, both for supplies and procedures

 Facility: Ensure to capture supplies appropriately.

 For investigational device, use rev code 624-Investigational Device, insert the FDA IDE number into the charge code name, set price appropriately (i.e.. if provided at no cost, set price of supply to $0.01)

 Professional Fee: Ensure applicable procedure codes are available for use by coding staff.

Successful Clinical Trial Information Capture

 Business Office:

 Thoroughly review Chapter 32 Section 68 and 69 of Medicare Claims Processing Manual for the necessary data capture that needs to be applied to specific FL positions on both the UB-04 and CMS 1500 claim forms.

 UB-04:





CC 30 to FL 18

Value Code D4 to FL 41, amount set to NCT number

 Ensure the charge for the supply itself is displaying properly:

 If investigational device, FL 42 reports appropriate revenue code (624)

 Outpatient: Description FL 43 includes the IDE number (starts with a G). If not investigational, this should display revenue code 278 for an implanted device

 A device provided at no cost should have a price of $0.01

 Outpatient: Condition code 53 Applied to FL 18/19, and Value Code FD in FL 41 with total amount credited in the amount column.

 Ensure Z00.6 is applied to diagnosis list in primary or secondary position,

 For profee and outpatient facility claims: modifier Q0/Q1 applied to correct CPT codes.

Successful Clinical Trial Information Capture

 CMS 1500:

 NCT number is listed in Field 19, with letters “CT” preceding the number

 IDE number is reported in Field 23

 Ensure Z00.6 is applied to diagnosis list in primary or secondary position

 Modifier Q0 applied to CPT code

 As the clinical trial is underway:

 Ensure any prior authorizations and ABNs are captured prior to each procedure.

 Ensure patient status is appropriately reviewed and assigned with help from UR.

 Facilitate education connections between clinical staff and coding staff

 Make sure medical record documentation is complete and accurate.

 Monitor coding and claims as they are populated, transmitted, and adjudicated.

 Work closely with denial specialists if any issues come up

 Have Clinical Trials department send trial rosters to coding staff at regular intervals.

Poll #2

Do you have a clear process in place to capture and disseminate essential information on patients that are a part of a clinical trial?

a. Yes

b. No

c. We are working on it

CPT Code Set: Overview

Poll #3

What cardiac valve area are you most interested in learning more about?

a. Aortic Valve

b. Mitral Valve

c. Pulmonary Valve

d. Tricuspid Valve

e. All of them

Coding Points for Transcatheter Cardiac Valve Procedures

 Overarching Key Coding Points:

 Many of these procedures are inpatient only status.

 Understanding the CPT code set is important for both facility and profee coding.

 Facility: Even though many of these cases are IP only, its critical to understand the CPT code set to accurately capture hospital line-item charges that will roll up into your total charges for your claims, especially on those paid on a percent of charge methodology and not necessarily solely on MS-DRG.

 Professional: CPT is the driver for reimbursement for physician coding and billing.

 Stay up to date on latest CPT coding changes as innovation rapidly expands this area of medicine.

 Be aware of AMA Symposium Discussions, July 1 CPT and HCPCS updates, and end of year CPT Updates, along with ICD-10-PCS coding updates.

 Facility Department Charge Capture, CDM, OP Coding and IP Coding, and Profee coding should continually communicate on proper coding capture across all methodologies

 Stay up to date on new advancements in structural heart intervention options.

 JSCAI, Frontiers, Cardiac Interventions Today, EP/Cath Lab Digest

Coding Points for Transcatheter Cardiac Valve Procedures

 Overarching Key Coding Points:

 Know your NCD requirements, Review NCAs and LCDs, along with 3PP Policies

 There are currently two active NCDs: TAVR and TMVr/TEER

 They require registry participation and/or Clinical Trial participation as conditions of coverage.

 Modifier Q0 required on applicable CPTs along with additional claim details.

 Some 3PP have policies regarding valve in valve replacements, that require the use of unlisted procedure codes instead of established code set for these patient populations.

Key Coding Points for Transcatheter Cardiac Valve Procedures

Key Documentation Points for Transcatheter Cardiac Valve Procedures

 Key Operative Note Documentation Points:

 For co-surgeon cases, each provider should complete their own notes detailing their involvement in the procedure, it should be clear how each participated in the procedure and at what points.

 Keep access site consistent and clear throughout note. Making it clear whether approach was open or percutaneous, and what the access site vessel was.

 Identify when surgical backup is on standby and when utilized. If they are activated and case converts to OR case, ensure that is made clear in note. OR surgeon should detail own note in this case delineating services rendered.

 Detail any adjunctive procedures performed and for what purpose.

 Including device trade names, when available/allowed is helpful to coders when determining appropriate code assignment.

 Identifying when a patient is participating in clinical trial within the operative note or supplemental medical record documentation

Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI)

Aortic Valve: TAVR/TAVI: Code Set

 Transcatheter Aortic Valve

Replacement/Implantation (TAVR, TAVI)

 CPT Code Range 33361-33366

 Composition by Approach/Location

 33361: Percutaneous Femoral Artery

 33362: Open Femoral Artery

 33363: Open Axillary Artery

 33364: Open Iliac Artery

 33365: Transaortic (e.g. median sternotomy, mediastinotomy)

 33366: Transapical Exposure (e.g. left thoracotomy)

 Most common approach is percutaneous

femoral/open femoral.

Aortic Valve: TAVR/TAVI: Code Set

 Transcatheter Aortic Valve Replacement/Implantation (TAVR, TAVI)

 CPT Code Range Full Definitions

 33361: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

 33362: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

 33363: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open

axillary artery approach

 33364: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

 33365: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy)

 33366: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)

Aortic Valve: TAVR/TAVI: Procedure Description

 First TAVR/TAVI performed in 2002. Code Set Developed in 2013

 Procedure Description: A guidewire is directed via the access to the left ventricle. A balloon catheter is delivered across the aortic valve and is inflated, compressing the native or prosthetic valve. A self expandable bioprosthetic valve is deployed across the valve treatment zone.

 Indications for Procedure:

 Symptomatic Aortic Stenosis

 Aortic Valve Disease

 Aortic Regurgitation

 Aortic Valve Insufficiency

 Bicuspid Aortic Valve

Aortic Valve: TAVR/TAVI: National Coverage Determination

 TAVR/TAVI coverage indications are outlined by CMS in NCD 20.32:

 TAVR is covered when:

1. Performed for the treatment of aortic valve stenosis, according to FDA approved indication, and following are met:

 Complete aortic valve implantation system used with FDA premarket approval

 Patient is under care of a “heart team”

 = cardiac surgeon, interventional cardiologist

 Independent face to face patient examination with review of options SAVR, TAVR, or palliative therapy.

 Rationale for clinical judgement documented

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure

 In a hospital with onsite valve surgery and interventional cardiology services, experienced post procedure care unit, and meeting procedure volume metrics

 The heart team and hospital participate in a nationally audited registry meeting data collection requirements outlined in the NCD

Aortic Valve: TAVR/TAVI: National Coverage Determination

 TAVR/TAVI coverage indications are outlined by CMS in NCD 20.32:

 TAVR is covered when:

2. For a non-FDA approved indication when performed within a clinical study when:

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure.

 The clinical research study evaluates quality of life pre and post TAVR for at least a year.

 The study adheres to outlined standards of scientific integrity and relevance to the beneficiaries.

 Review of cardiac registry and clinical studies approved for Medicare coverage can be found on CMS.gov webpage Coverage with Evidence Development

 Transcatheter Aortic Valve Replacement

 STS/ACC Transcatheter Valve Therapy (TVT) Registry

 20+ Clinical Trials

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Included Components (Do Not Report Separately)

 Percutaneous access/sheath placement/delivery system advancement

 Cutdown Procedures: 34812-34716

 BAV: 92986

 Temporary pacing: 33210

 Angiography, Roadmapping, RSI to guide procedure

 Closure of arteriotomy

 Nondiagnostic left heart catheterization: (93452, 93453, 93458-93461)

 Supravalvular Aortography: 93567

 Clinical Trial/Registry Participation is required per NCD 20.22, apply modifier Q0/Q1 to CPT code when applicable (Hospital OP, All Professional Fee Claims)

 All procedures require two physicians to perform the service per NCD, apply modifier -62 to all codes. Status indicator is 2

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Cardiopulmonary Bypass Support:

 +33367- +33369

 Transcatheter Cerebral Embolic Protection: +33370

 Sentinel or TriGuard 3 systems

 Includes: Arterial access, placement of catheters, delivery of initial/addl filter(s), removal of filter(s) and debris, removal of equipment and closure of arteriotomy, RSI and imaging guidance (+76937, 75600, 75710)

 Separately report extensive repair of arteriotomy: 35226-35286

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Separately Reportable Procedures:

 Ventricular Support

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 - 33995

 ECMO/ECLS: 33946 - 33989

 Intra Aortic Balloon Pump (IABP): 33967, 33970-33973

 Debulking of Intracardiac Vegetations/Masses with Suction (Angiovac): 0644T

 Bioprosthetic Aortic Scallop Intentional Laceration (BASILICA): Unlisted Procedure Code

93799

 Prevents coronary artery obstruction

 Other cardiac catheterization services not intrinsic to TAVR/TAVI

 Medically necessary diagnostic coronary angiography (93454, 93455)

 Percutaneous Coronary Intervention (PCI): 92920-92944/C9600-C9608

Aortic Valve: TAVR/TAVI: Medical Devices

 Bioprosthetic Valves for TAVR/TAVI

 Boston Scientific Accurate NEO

 Boston Scientific Accurate TA

 Boston Scientific Lotus

 NVT Allegra

 Medtronic Evolut Pro

 Edwards Lifesciences Sapien 3 Ultra

 Edwards Lifesciences S3

 JenaValve Triology Heart Valve System

 Meril MyVal

 Abbott Portico

 HCPCS Code for Facility Billing: None, Use revenue code 278 or 624

 Clinical Trials – TAVR/TAVI

 Evolut™ EXPAND TAVR II Pivotal Trial:NCT05149755

 ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve: NCT05172960

 ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4

Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves: NCT05172973

 PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS): NCT04889872

 The JenaValve ALIGN-AR Pivotal Trial

(ALIGN-AR): NCT04415047

Transcatheter Mitral Valve Repair/Transcatheter Edge to Edge Repair (TMVr/TEER)

Mitral Valve: TMVr/TEER: Code Set

 Transcatheter Mitral Valve Repair (TMVr, TEER) CPT Code Range:

 33418: Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

 33419: additional prosthesis(es) during same session (List separately in addition to code for primary procedure)

 0543T: Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae

Mitral Valve: TMVr/TEER : CPT Procedure Description

 First 33418/33419 procedure performed in 2003 in Venezuela. CPT Code 33418/33419 Developed in 2015. 0543T in 2019.

 Code Description:

 33418/33419: From the access point a catheter is delivered to the mitral valve where a clip(s) is attached to the edges of multiple leaflets to join them back together (Mitraclip), (TEER)

 0543T: Using a transapical approach with TEE guidance, a transcatheter device is inserted into the left ventricle, anchored to the cardiac wall, and then additionally inserted through an affected mitral valve leaflet and anchored. This leaves sutures in place to create an artificial replacement for ruptured chordae tendinea and reverses mitral regurgitation. (HARPOON, NeoChord)

 Possible Indications for Procedure:

 Functional Mitral Regurgitation

Mitral Valve: TMVr/TEER : National Coverage Determination

 TMVr/TEER coverage indications are outlined by CMS in NCD 20.33

 TMVr/TEER is covered when:

1. For the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or for the treatment of significant symptomatic degenerative MR when furnished according to a Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met:

 Procedure is furnished with a mitral valve TEER system that has received FDA premarket approval (PMA)

 Patient is under care of a “heart team” = cardiac surgeon, interventional cardiologist, interventional echocardiographer, and a heart failure cardiologist, etc.

 Suitability for surgical mitral valve repair, TEER, or palliative therapy must be evaluated, documented, and made available to other heart team members

Mitral Valve: TMVr/TEER: National Coverage Determination

 Interventional cardiologist or cardiac surgeon from the heart team must perform the mitral valve TEER and an interventional echocardiographer from the heart team must perform transesophageal echocardiography during the procedure.

 Mitral valve TEERs must be furnished in a hospital with appropriate infrastructure and experience.

 The heart team and hospital are participating in a prospective, national, audited registry.

 Registry shall collect all data necessary and have a written executable analysis plan in place to address specific outcomes outlined in 20.33.

Mitral Valve: TMVr/TEER: National Coverage Determination

2. Mitral valve TEERs are covered for uses that are not expressly listed as an FDAapproved indication when performed within a clinical study that fulfills all of the following:

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure.

 The clinical research study evaluates quality of life pre and post TAVR for at least a year.

 The study adheres to outlined standards of scientific integrity and relevance to the beneficiaries.

 Review of TEER related clinical trials can be found on clinicaltrials.gov search for “mitral regurgitation” in Condition or Disease search. And “mitraclip, TEER” in Other Terms search.

Mitral Valve: TMVr/TEER : National Coverage Determination

 Nationally Non-Covered Indications

 TEER of the mitral valve is not covered under the following circumstances:

 1. For patients in whom existing co-morbidities would preclude the expected benefit from a mitral valve TEER procedure.

 2. In patients with untreated severe aortic stenosis.

 TMVr coverage via HARPOON, Neochord (0543T) is not subject to NCD 20.33

 No national coverage determination currently exists

 No requirement for registry data collection.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare or other 3PP

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Clinical Trial/Registry Participation is required per NCD 20.33, apply modifier Q0/Q1 to CPT codes when applicable (Hospital OP, All Professional Fee Claims)

 The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving mitral valve therapies.

 Included Components (Do Not Report Separately)

 CPT 33418/33419:

 Access and delivery of device to heart

 Transseptal access: 93462

 Repositioning and deployment of device(s)

 Angiography, RSI, and roadmapping

 Nondiagnostic heart catheterization and coronary angiography

 CPT 0543T:

 Transthoracic Echocardiographic Guidance (TTE)

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Separately Reportable Procedures

 CPT 33418/33419:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 Percutaneous coronary intervention: 92920-92944, C9600-C9608

 Cardiopulmonary Bypass Support: +33367- +33369

 Ventricular Support:

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 - 33995

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Separately Reportable Procedures

 CPT 0543T:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

Mitral Valve: TMVr/TEER: Medical Devices

 Transcatheter Mitral Valve Repair Devices

 Abbott: MitraClip

 Edwards LifeSciences: HARPOON

 Neochord Inc: Neochord

 Transcatheter Mitral Valve Repair Clinical Trials

 GISE Registry of Transcatheter

Treatment of Mitral Valve Regurgitation

With the MitraClip G4: NCT05455489

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Change in LVEF Following

Transcatheter Mitral Edge-To-Edge

Repair (MITRA-EF): NCT05311163

 Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device. (ASCEND):

Terminated: NCT04382612

 Safety and Performance Study of the NeoChord Device (TACT): Completed: NCT01777815

Reference Links

 Cardiac Interventions Today:

 https://citoday.com/device-guide/us#structural-heart

 Frontiers

 https://www.frontiersin.org/articles/10.3389/fcvm.2020.531843/full

 CMS MCD Database:

 https://www.cms.gov/medicare-coverage-database/search.aspx

 CMS Medicare Coverage Document Type Descriptions:

 https://www.cms.gov/medicare-coveragedatabase/help/Document_Type_Descriptions.pdf

 NCDR TVT Registry

 https://www.ncdr.com/WebNCDR/tvt/publicpage/data-collection

 Journal of the Society for Cardiovascular Angiography and Interventions

 https://www.jscai.org/article/S2772-9303(22)00575-0/fulltext

 Smart Phone Apps by Developer Krutsch: ViV Aortic, ViV Mitral, and ViV PPM

Reference Links

 Medicare Claims Processing Manual Chapter 3,4, and 32

 NCD 20.32

 https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=355

 NCD 20.33

 https://www.cms.gov/medicare-coveragedatabase/view/ncd.aspx?NCDId=363&ncdver=1

 CPT Expert 2023

 ClinicalTrials.gov

Additional Resource Slides: Transcatheter

Valve Procedures

By Cardiac Valve

Transcatheter Aortic Valve Procedures

TAVR/TAVI

Balloon Aortic Valvuloplasty

Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI)

Aortic Valve: TAVR/TAVI: Code Set

 Transcatheter Aortic Valve

Replacement/Implantation (TAVR, TAVI)

 CPT Code Range 33361-33366

 Composition by Approach/Location

 33361: Percutaneous Femoral Artery

 33362: Open Femoral Artery

 33363: Open Axillary Artery

 33364: Open Iliac Artery

 33365: Transaortic (e.g. median sternotomy, mediastinotomy)

 33366: Transapical Exposure (e.g. left thoracotomy)

 Most common approach is percutaneous

femoral/open femoral.

Aortic Valve: TAVR/TAVI: Code Set

 Transcatheter Aortic Valve Replacement/Implantation (TAVR, TAVI)

 CPT Code Range Full Definitions

 33361: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

 33362: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

 33363: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach

 33364: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

 33365: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy)

 33366: Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)

Aortic Valve: TAVR/TAVI: Procedure Description

 First TAVR/TAVI performed in 2002. Code Set Developed in 2013

 Procedure Description: A guidewire is directed via the access to the left ventricle. A balloon catheter is delivered across the aortic valve and is inflated, compressing the native or prosthetic valve. A self expandable bioprosthetic valve is deployed across the valve treatment zone.

 Indications for Procedure:

 Symptomatic Aortic Stenosis

 Aortic Valve Disease

 Aortic Regurgitation

 Aortic Valve Insufficiency

 Bicuspid Aortic Valve

Aortic Valve: TAVR/TAVI: National Coverage Determination

 TAVR/TAVI coverage indications are outlined by CMS in NCD 20.32:

 TAVR is covered when:

1. Performed for the treatment of aortic valve stenosis, according to FDA approved indication, and following are met:

 Complete aortic valve implantation system used with FDA premarket approval

 Patient is under care of a “heart team”

 = cardiac surgeon, interventional cardiologist

 Independent face to face patient examination with review of options SAVR, TAVR, or palliative therapy.

 Rationale for clinical judgement documented

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure

 In a hospital with onsite valve surgery and interventional cardiology services, experienced post procedure care unit, and meeting procedure volume metrics

 The heart team and hospital participate in a nationally audited registry meeting data collection requirements outlined in the NCD

Aortic Valve: TAVR/TAVI: National Coverage Determination

 TAVR/TAVI coverage indications are outlined by CMS in NCD 20.32:

 TAVR is covered when:

2. For a non-FDA approved indication when performed within a clinical study when:

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure.

 The clinical research study evaluates quality of life pre and post TAVR for at least a year.

 The study adheres to outlined standards of scientific integrity and relevance to the beneficiaries.

 Review of cardiac registry and clinical studies approved for Medicare coverage can be found on CMS.gov webpage Coverage with Evidence Development

 Transcatheter Aortic Valve Replacement

 STS/ACC Transcatheter Valve Therapy (TVT) Registry

 20+ Clinical Trials

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Included Components (Do Not Report Separately)

 Percutaneous access/sheath placement/delivery system advancement

 Cutdown Procedures: 34812-34716

 BAV: 92986

 Temporary pacing: 33210

 Angiography, Roadmapping, RSI to guide procedure

 Closure of arteriotomy

 Nondiagnostic left heart catheterization: (93452, 93453, 93458-93461)

 Supravalvular Aortography: 93567

 Clinical Trial/Registry Participation is required per NCD 20.22, apply modifier Q0/Q1 to CPT code when applicable (Hospital OP, All Professional Fee Claims)

 All procedures require two physicians to perform the service per NCD, apply modifier -62 to all codes. Status indicator is 2

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Cardiopulmonary Bypass Support:

 +33367- +33369

 Transcatheter Cerebral Embolic Protection: +33370

 Sentinel or TriGuard 3 systems

 Includes: Arterial access, placement of catheters, delivery of initial/addl filter(s), removal of filter(s) and debris, removal of equipment and closure of arteriotomy, RSI and imaging guidance (+76937, 75600, 75710)

 Separately report extensive repair of arteriotomy: 35226-35286

Aortic Valve: TAVR/TAVI: CPT Key Coding Points

 Separately Reportable Procedures:

 Ventricular Support

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 - 33995

 ECMO/ECLS: 33946 - 33989

 Intra Aortic Balloon Pump (IABP): 33967, 33970-33973

 Debulking of Intracardiac Vegetations/Masses with Suction (Angiovac): 0644T

 Bioprosthetic Aortic Scallop Intentional Laceration (BASILICA): Unlisted Procedure Code

93799

 Prevents coronary artery obstruction

 Other cardiac catheterization services not intrinsic to TAVR/TAVI

 Medically necessary diagnostic coronary angiography (93454, 93455)

 Percutaneous Coronary Intervention (PCI): 92920-92944/C9600-C9608

Aortic Valve: TAVR/TAVI: Medical Devices

 Bioprosthetic Valves for TAVR/TAVI

 Boston Scientific Accurate NEO

 Boston Scientific Accurate TA

 Boston Scientific Lotus

 NVT Allegra

 Medtronic Evolut Pro

 Edwards Lifesciences Sapien 3 Ultra

 Edwards Lifesciences S3

 JenaValve Triology Heart Valve System

 Meril MyVal

 Abbott Portico

 HCPCS Code for Facility Billing: None, Use revenue code 278 or 624

 Clinical Trials – TAVR/TAVI

 Evolut™ EXPAND TAVR II Pivotal Trial:NCT05149755

 ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve: NCT05172960

 ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4

Transcatheter Heart Valve in Failing Aortic Surgical Bioprosthetic Valves: NCT05172973

 PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS): NCT04889872

 The JenaValve ALIGN-AR Pivotal Trial

(ALIGN-AR): NCT04415047

Balloon Aortic Valvuloplasty (BAV)

Aortic Valve: BAV: Code Set

 Balloon Aortic Valvuloplasty (BAV)

 CPT Code

 92986: Percutaneous balloon valvuloplasty; aortic valve

Aortic Valve: BAV: CPT Procedure Description

 CPT Procedure Description

 Code Developed in 1993

 Code Description: This code describes transcatheter delivery of a balloon to the aortic valve where the balloon is positioned across the valve and inflated to dilate the narrowed or blocked valve.

 Possible Indications for Procedure:

 In light of the development of TAVR/TAVI, BAV is a destination therapy for patients currently excluded from TAVR/TAVI indications or as a bridging therapy to SAVR or TAVR/TAVI.

 Aortic valve stenosis which when left untreated can lead to heart failure and development of arrythmia.

Aortic Valve: BAV: National Coverage Determination

 No active NCD on BAV

 The National Heart Lung and Blood Institute (NHLBI) Balloon Valvuloplasty Registry collected data on patients undergoing BAV in the USA and Canada between 1987 and 1989 and is now closed.

 Mansfield Scientific Aortic Valvuloplasty Registry collected data from 1986 to 1987.

Aortic Valve: BAV: Key CPT Coding Points

 Included Components (Do Not Report Separately)

 Catheter placement

 RSI, Roadmapping, and imaging guidance to perform the procedure

 Nondiagnostic heart catheterization: for pressure gradient measurement

 Nondiagnostic Ventriculography: contrast injections

 Hemostasis

 Separately Reportable Procedures:

 Atrial septectomy or septostomy, transvenous, balloon or blade: 33741

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 BAV is a component of the following codes and cannot be reported separately:

 TAVR/TAVI: 33361-33369

 Cerebral Embolic Protection: 33370

 Open approach aortic valvuloplasty: 33390, 33391

 Open approach aortic valve replacement: 33405-33440

 Percutaneous transcatheter closure of paravalvular leak: 93590-93592

Aortic Valve: BAV: Medical Devices and Clinical Trials

 BAV Devices/Balloons

 Z-MED: Balloon Aortic and Pulmonic

Valvuloplasty Catheters

 B. Braun: Nucleus-X Balloon Aortic & Pulmonic Valvuloplasty Catheter

 BD Interventional: True Dilatation

Balloon Valvuloplasty Catheter

 Clinical Trials

 Mini-invasive Balloon Aortic

Valvuloplasty (SOFTLY-II):

NCT03087552: (Completed)



Getinge: V8 Valvuloplasty Aortic

Balloon Catheter

 Toray International: Inoue-Balloon

Catheter

 HCPCS Code for Facility Billing: C1725

 Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement (BAV-SAVR) : NCT00584116: (Completed)

 Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis (RADAR): NCT00538759

(Terminated)

 Assessment of the Role of Balloon

Aortic Valvuloplasty in the Management of Patients With Aortic

Stenosis: NCT02122900 (Completed)

Transcatheter Mitral Valve Procedures

TMVR/TMVI

Balloon Mitral Valvuloplasty

Mitral Annulus Reconstruction

TMVr/TEER

Transcatheter Mitral Valve Replacement/Implantation

Mitral Valve: TMVR/TMVI: Code Set

 Transcatheter Mitral Valve

Replacement/Implantation (TMVR/TMVI)

 CPT Code Range 0483T, 0484T

 0483T: Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed.

 0484T: Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (e.g., thoracotomy, transapical)

Mitral Valve: TMVR/TMVI: CPT Procedure Description/National Coverage Determination

 First Procedure Performed 2012. Code Set Developed in 2018

 Procedure Description: Through the access point, a catheter is advanced to the left atrium/left ventricle. Balloon valvuloplasty is performed to compress the native or prosthetic valve. A mitral valve prosthesis is delivered via a transcatheter approach and deployed across the valve.

 0483T: Delivery and deployment via venous approach to the right atrium. A transseptal puncture from the RA to LA is performed. A catheter crosses into the left ventricle and across the mitral valve.

 0484T: Delivery and deployment via a thoracotomy or trans-apical puncture into the left ventricle and across the mitral valve.

 Possible Indications for Procedure: Symptomatic mitral regurgitation or mitral stenosis who are too high risk for open heart surgery

Mitral Valve: TMVR/TMVI: National Coverage Determination

 No active NCD on TMVR/TMVI currently

 The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving mitral valve therapies.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare

Mitral Valve: TMVR/TMVI: Key CPT Coding Points

 Procedures Included in TMVR/TMVI

 Vascular access

 Valvuloplasty: 92987

 Transseptal access: 93462

 Valve deployment/repositioning

 Cardiac catheterization: 93451-93453

 Nondiagnostic Angiography: 93454-93461

 Nondiagnostic Left Ventriculography: 93452

 RSI, Roadmapping, Fluoroscopy to guide procedure

 Temporary pacing: 33210

 Closure of access site: G0269

Mitral Valve: TMVR/TMVI: Key CPT Coding Points

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Intracardiac Echocardiography (ICE): 93662

 Laceration of the Anterior Mitral leaflet to Prevent Outflow Obstruction (Lampoon)

Procedure: Unlisted Procedure 93799

 Prevents LVOT

 Diagnostic Heart Catheterization (Right and Left), and Coronary Angiography: 9345193461

 Percutaneous Coronary Intervention: 92920-92944/C9600-C9608

 Percutaneous Transcatheter Tricuspid Valve Annulus Reconstruction: 0545T

 ECMO/ECLS: 33946 – 33989

 Cardiopulmonary Bypass Support:

 +33367- +33369

Mitral Valve: TMVR/TMVI: Key CPT Coding Points

 Separately Reportable Procedures:

 Ventricular Support

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 – 33995

 Additional Coding Considerations

 What if an approach is used that isn’t a part of code set?

 Use Unlisted Procedure Code 33999

 Should the placement of a shunt for successful delivery of a transcatheter valve be coded separately?

 Use of a shunt to successfully place a valve should not be separately reported.

 Procedure is co-surgery eligible (Modifier -62, Indicator =2)

 The TMVR code set may be used for patients who have a previously placed valve in place in addition to those who have never had valve surgery before.

 Documentation might specify this population as THV in THV, THV in SAV, or Valve in Valve

 Some payers require this is reported as unlisted procedure code (ie 33999)

Mitral Valve: TMVR/TMVI: Key CPT Coding Points

 Pre-TMVR Balloon Mitral Valvuloplasty (BMV) of a native or previously implanted prosthetic valve (i.e.. “cracking”) is not separately reported with 92987.

 Diagnostic Heart Catheterization/Coronary Angiography (i.e.. CPTs 93451-93461, 9292092944/C9600-C9608) may be separately reported only when no prior catheter-based study is available, clinical indications have changed since prior study, or previous imaging is suboptimal.

 Diagnostic Heart Catheterization/Coronary Angiography (i.e.. CPTs 93451-93461, 92920-92944/C9600-C9608) may be separately reported only when no prior catheterbased study is available, clinical indications have changed since prior study, or previous imaging is suboptimal.

 How to capture intracardiac shockwave IVL prior to valve placement to treat mitral annular calcification?: Unlisted CPT 33999

 Temporary pacing (CPT 33210) is included in the TMVR code set and not separately reported.

Mitral Valve: TMVR/TMVI: Medical Devices

 TMVR/TMVI Medical Devices

 Edwards Life Sciences: Sapien 3

 Meril: MyVal

 Abbott Tendyne

 Medtronic: Intrepid

 Neovasc: TIARA

 Edwards LifeSciences: Sapien M3

 LivaNova: Caisson

 HighLife SAS: HighLife

 Edwards LifeSciences: Fortis

 CardioValve: CardioValve

 Edwards LifeSciences: Evoque

HCPCS Code for Facility Billing: No

HCPCS Code, list device with revenue code 278 or 624

 TMVR/TMVI Clinical Trials

 Tiara™ Transcatheter Mitral Valve

Replacement Study (TIARA-II):

Neovasc: NCT03039855

 Caisson Transcatheter Mitral Valve

Replacement (TMVR) (INTERLUDE):

Caisson: NCT03661398

 HighLife™ Transcatheter Mitral Valve

Replacement System Study: HighLife

SAS: NCT02974881

 Mi-thos® Transcatheter Mitral Valve

Replacement Study: Shanghai

NewMed Medical Co., Ltd.:

NCT04195984

Balloon Mitral Valvuloplasty (BMV)

Mitral Valve: BMV: Code Set

 Balloon Mitral Valve (BMV)

 CPT Code Range

 92987: Percutaneous balloon valvuloplasty; mitral valve

Mitral Valve: BMV: CPT Procedure Description/National Coverage

Determination

 CPT Procedure Description

 First performed in 1984 (Kanji Inoue). CPT Code Developed in 1996

 Code Description: This code describes transcatheter delivery of a balloon to the mitral valve where the balloon is positioned across the valve and inflated to dilate the narrowed or blocked valve.

 Possible Indications for Procedure:

 Severe Rheumatic Mitral Stenosis

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. M-Heart percutaneous balloon mitral Valvuloplasty Registry previously collected data in the 1990s.

Mitral Valve: BMV: Key CPT Coding Points

 Included Components (Do Not Report Separately)

 Catheter placement

 RSI, Roadmapping, and imaging guidance to perform the procedure

 Nondiagnostic heart catheterization: for pressure gradient measurement

 Nondiagnostic atrial/ventricular angiography

 Hemostasis

 Separately Reportable Procedures:

 Atrial septectomy or septostomy, transvenous, balloon or blade: 33741

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 BMV is a component of the following codes and cannot be reported separately:

 Transcatheter mitral valve repair (TMVr/TEER, MitraClip): 33418

 Valvotomy, open/closed, mitral: 33420, 33422

 Valvuloplasty, open, mitral: 33425-33427

 Surgical mitral valve replacement: 33430

Mitral Valve: BMV: Medical Devices and Clinical Trials

 BMV Devices/Balloons

 BD Interventional: True Dilatation Balloon Valvuloplasty Catheter

 B. Braun Interventional Systems, Inc: Tyshak II

 B. Braun Interventional Systems, Inc: Z-Med Balloon

 Toray International: Inoue-Balloon Catheter

 HCPCS Code for Facility Billing: C1725

 BMV Clinical Trials

 Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study: Duk-Woo Park, MD: NCT04351984

Transcatheter Mitral Valve Annulus Reconstruction

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction: Code Set

 Transcatheter Mitral Valve Annulus

Reconstruction CPT Code Range:

 0544T: Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture

 0345T: Transcatheter mitral valve repair percutaneous approach via the coronary sinus

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction : CPT

Procedure Description

 CPT 0544T Code Developed in 2019. 0345T in 2014

 Code Description:

 0544T: This code describes transcatheter delivery of an adjustable annulus ring. It is secured to annulus of the mitral valve by steel anchors. Once secured, the device is then contracted to reform the shape of the mitral valve, bringing the valve leaflets closer together. (Cardioband)

 0345T: Via a transvenous approach, the coronary sinus is cannulated. Anatomically, the coronary sinus “hugs” the mitral valve. A transcatheter device is threaded into the coronary sinus and anchored in place. The device is cinched and it causes the annulus of the mitral valve to contract, bringing the mitral valve leaflets closer together. Over time the device dissolves. (Carillon Mitral Contour System)

 Possible Indications for Procedure:

 Functional Mitral Regurgitation

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction : National Coverage

Determination

 No national coverage determination currently exists

 No requirement for registry data collection.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction : Key

CPT Coding Points

 Included Components (Do Not Report Separately)

 Vascular access and catheterization

 Device deployment and adjustment

 Temporary pacing: 33210

 Access Site Closure

 Angiography, RSI, roadmapping inherent to device implant

 Ventriculography and completion angiography

 Nondiagnostic heart catheterization and angiography

 Transseptal Puncture: 93462

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Diagnostic Heart Catheterization (Right and Left), and Coronary Angiography: 9345193461

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction : Key

CPT Coding Points

 Separately Reportable Procedures:

 Percutaneous Coronary Intervention: 92920-92944/C9600-C9608

 Cardiopulmonary Bypass Support: for 0544T only

 +33367- +33369

 Ventricular Support:

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 - 33995

Mitral Valve: Transcatheter Mitral Valve Annulus Reconstruction: Medical Devices

 Transcatheter Mitral Valve Annulus

Reconstruction Devices

 Edwards LifeSciences: Cardioband

 Cardiac Dimensions: Carillon Contour

System

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Transcatheter Mitral Valve Annulus

Reconstruction Clinical Trials

 Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

(ACTIVE): Edwards LifeSciences: NCT03016975

 TRI-REPAIR: TrIcuspid Regurgitation

RePAIr With CaRdioband Transcatheter

System (TRI-REPAIR): Completed:

Edwards LifeSciences: NCT02981953

 EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart

Failure With at Least Mild FMR: NCT03142152

Transcatheter Mitral Valve Repair/Transcatheter Edge to Edge Repair (TMVr/TEER)

Mitral Valve: TMVr/TEER: Code Set

 Transcatheter Mitral Valve Repair (TMVr, TEER) CPT Code Range:

 33418: Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

 33419: additional prosthesis(es) during same session (List separately in addition to code for primary procedure)

 0543T: Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae

Mitral Valve: TMVr/TEER : CPT Procedure Description

 First 33418/33419 procedure performed in 2003 in Venezuela. CPT Code 33418/33419 Developed in 2015. 0543T in 2019.

 Code Description:

 33418/33419: From the access point a catheter is delivered to the mitral valve where a clip(s) is attached to the edges of multiple leaflets to join them back together (Mitraclip), (TEER)

 0543T: Using a transapical approach with TEE guidance, a transcatheter device is inserted into the left ventricle, anchored to the cardiac wall, and then additionally inserted through an affected mitral valve leaflet and anchored. This leaves sutures in place to create an artificial replacement for ruptured chordae tendinea and reverses mitral regurgitation. (HARPOON, NeoChord)

 Possible Indications for Procedure:

 Functional Mitral Regurgitation

Mitral Valve: TMVr/TEER : National Coverage Determination

 TMVr/TEER coverage indications are outlined by CMS in NCD 20.33

 TMVr/TEER is covered when:

1. For the treatment of symptomatic moderate-to-severe or severe functional mitral regurgitation (MR) when the patient remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, or for the treatment of significant symptomatic degenerative MR when furnished according to a Food and Drug Administration (FDA)-approved indication and when all of the following conditions are met:

 Procedure is furnished with a mitral valve TEER system that has received FDA premarket approval (PMA)

 Patient is under care of a “heart team” = cardiac surgeon, interventional cardiologist, interventional echocardiographer, and a heart failure cardiologist, etc.

 Suitability for surgical mitral valve repair, TEER, or palliative therapy must be evaluated, documented, and made available to other heart team members

Mitral Valve: TMVr/TEER: National Coverage Determination

 Interventional cardiologist or cardiac surgeon from the heart team must perform the mitral valve TEER and an interventional echocardiographer from the heart team must perform transesophageal echocardiography during the procedure.

 Mitral valve TEERs must be furnished in a hospital with appropriate infrastructure and experience.

 The heart team and hospital are participating in a prospective, national, audited registry.

 Registry shall collect all data necessary and have a written executable analysis plan in place to address specific outcomes outlined in 20.33.

Mitral Valve: TMVr/TEER: National Coverage Determination

2. Mitral valve TEERs are covered for uses that are not expressly listed as an FDAapproved indication when performed within a clinical study that fulfills all of the following:

 Cardiac surgeon and interventional cardiologist jointly perform intraoperative aspects of procedure.

 The clinical research study evaluates quality of life pre and post TAVR for at least a year.

 The study adheres to outlined standards of scientific integrity and relevance to the beneficiaries.

 Review of TEER related clinical trials can be found on clinicaltrials.gov search for “mitral regurgitation” in Condition or Disease search. And “mitraclip, TEER” in Other Terms search.

Mitral Valve: TMVr/TEER : National Coverage Determination

 Nationally Non-Covered Indications

 TEER of the mitral valve is not covered under the following circumstances:

 1. For patients in whom existing co-morbidities would preclude the expected benefit from a mitral valve TEER procedure.

 2. In patients with untreated severe aortic stenosis.

 TMVr coverage via HARPOON, Neochord (0543T) is not subject to NCD 20.33

 No national coverage determination currently exists

 No requirement for registry data collection.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare or other 3PP

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Clinical Trial/Registry Participation is required per NCD 20.33, apply modifier Q0/Q1 to CPT codes when applicable (Hospital OP, All Professional Fee Claims)

 The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving mitral valve therapies.

 Included Components (Do Not Report Separately)

 CPT 33418/33419:

 Access and delivery of device to heart

 Transseptal access: 93462

 Repositioning and deployment of device(s)

 Angiography, RSI, and roadmapping

 Nondiagnostic heart catheterization and coronary angiography

 CPT 0543T:

 Transthoracic Echocardiographic Guidance (TTE)

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Separately Reportable Procedures

 CPT 33418/33419:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 Percutaneous coronary intervention: 92920-92944, C9600-C9608

 Cardiopulmonary Bypass Support: +33367- +33369

 Ventricular Support:

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990 - 33995

Mitral Valve: TMVr/TEER : Key CPT Coding Points

 Separately Reportable Procedures

 CPT 0543T:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

Mitral Valve: TMVr/TEER: Medical Devices

 Transcatheter Mitral Valve Repair Devices

 Abbott: MitraClip

 Edwards LifeSciences: HARPOON

 Neochord Inc: Neochord

 Transcatheter Mitral Valve Repair Clinical Trials

 GISE Registry of Transcatheter

Treatment of Mitral Valve Regurgitation

With the MitraClip G4: NCT05455489

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Change in LVEF Following Transcatheter Mitral Edge-To-Edge

Repair (MITRA-EF): NCT05311163

 Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device. (ASCEND):

Terminated: NCT04382612

 Safety and Performance Study of the NeoChord Device (TACT): Completed: NCT01777815

Transcatheter Pulmonary Valve Procedures

TPVI/TPVR

Balloon Pulmonary Valvuloplasty

Transcatheter Pulmonary Valve Implantation/Replacement (TPVI/TPVR)

Pulmonary Valve : TPVI/TPVR : Code Set

 Transcatheter Pulmonary Valve

Implantation/Replacement (TPVI/TPVR)

CPT Code Range

 33477: Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed.

Pulmonary Valve : TPVI/TPVR : CPT Procedure Description/National Coverage Determination

 CPT Procedure Description

 First transcatheter pulmonary valve replacement was performed in 2000. CPT code created in 2016.

 Code Description: Via a venous access point, a catheter is threaded to the pulmonary artery. After angiography and hemodynamic study, a combination of angioplasty to evaluate coronary anatomy and stenting is performed to ancho implant in place. The prosthetic valve is deployed across the diseased valve.

 Possible Indications for Procedure: Pulmonary valve stenosis or regurgitation post repair of congenital RVOT abnormalities.

 National Coverage Determination

 No national coverage determination currently exists

 No requirement for registry data collection. A prior data registry existed specific to patients who received the Medtronic Melody valve from 2006 to 2013. The American College of Cardiology’s NCDR IMPACT Registry collects data on pediatric and adult congenital heart disease patients who have diagnostic and interventional catheterizations.

Pulmonary Valve : TPVI/TPVR : Key CPT Coding Points

 Included Components (Do Not Report Separately)

 Access, placement of catheters, advancement of device

 Repositioning of device

 Angiographic Roadmapping, RSI

 Nondiagnostic heart catheterization and coronary angiography

 Percutaneous balloon angioplasty, valvuloplasty, and stenting within the conduit/treatment zone

 Separately Reportable Procedures

 Percutaneous balloon angioplasty and stenting outside of the conduit/treatment zone: 92997, 92998, 37236, 37237

 RVOT Stent Placement: 33745, 33746

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 Percutaneous coronary intervention: 92920-92944, C9600-C9608

 Pulmonary artery branch interventions: 33990-33904, 92997, 92998,

Pulmonary Valve: TPVI/TPVR : Key CPT Coding Points

 Separately Reportable Procedures

 Cardiopulmonary Bypass Support: +33367- +33369

 ECMO/ECLS: 33946 – 33989

 Ventricular Support:

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990-33995



IABP: 33967-33973

Pulmonary Valve : TPVI/TPVR : Medical Devices

 Transcatheter Pulmonary Valve

Implantation/Replacement Devices

 Medtronic: Melody Valve

 Medtronic: Harmony Valve

 Autus Valve Technologies Inc: Autus Valve: Pediatric

 Edwards Lifesciences: Inspiris Valve

 Edwards Lifesciences: Sapien XT

 Transcatheter Pulmonary Valve

Implantation/Replacement Clinical Trials:

 Autus Valve Early Feasibility Study: Autus

Valve Technologies Inc: NCT05006404

 INSPIRIS

RESILIA Valve in Pulmonary Position: Medical University of Vienna: NCT05583656

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve

Dysfunction: Edwards Lifesciences: NCT02744677

Balloon Pulmonary Valvuloplasty (BPV)

CPT Code Range

 92990: Percutaneous balloon valvuloplasty; pulmonary valve

Pulmonary Valve : BPV : CPT Procedure Description/National Coverage

Determination

 CPT Procedure Description

 First transcatheter pulmonary balloon valvuloplasty was performed in 1985. CPT Code developed in 1993.

 Code Description: This code describes transcatheter delivery of a balloon to the pulmonary valve where the balloon is positioned across the valve and inflated to dilate the narrowed or blocked valve.

 Possible Indications for Procedure: Congenital pulmonary valve stenosis

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. The American College of Cardiology’s NCDR

IMPACT Registry collects data on pediatric and adult congenital heart disease patients who have diagnostic and interventional catheterizations.

Pulmonary Valve : BPV : Key Coding Points

 Included Components (Do Not Report Separately)

 Catheter placement

 RSI, roadmapping, and imaging guidance to perform the procedure

 Nondiagnostic heart catheterization: for pressure gradient measurement

 Nondiagnostic atrial/ventricular angiography

 Hemostasis

 Separately Reportable Procedures

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 BPV is a component of the following codes and cannot be reported separately:

 Transcatheter Pulmonary Valve Implantation/Replacement

Pulmonary Valve : BPV : Medical Devices

 Transcatheter Pulmonary Valve

Implantation/Replacement Devices

 B. Braun Interventional Systems, Inc.: Nucleus-X

 Boston Scientific: Diamond

 B. Braun Interventional Systems, Inc: Tyshak

II

 Vascular Concept: Accura Balloon

 Toray International America, INC: Inoue

 Transcatheter Pulmonary Valvuloplasty

Clinical Trials:

 The Outcome of Percutaneous Balloon

Pulmonary Valvuloplasty in Pediatrics:

Assiut University: NCT05748431

HCPCS Code for Facility Billing: C1725

Transcatheter Tricuspid Valve Procedures

TTVI/TTVR

Tricuspid Balloon Valvuloplasty

Annulus Repair

TTVr/TEER

Transcatheter Tricuspid Valve Implantation/Replacement (TTVI/TTVR)

Tricuspid Valve : TTVI/TTVR: Code Set

 Transcatheter Tricuspid Valve

Implantation/Replacement (TTVI/TTVR) CPT Code Range:

 0646T: Transcatheter tricuspid valve

implantation (TTVI)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed

Tricuspid Valve : TTVI/TTVR: CPT Procedure Description/National Coverage Determination

 CPT Procedure Description

 The first reported transcatheter tricuspid valve replacement was performed in 2011. 0646T established in 2021.

 Code Description: From a venous access approach, a catheter mounted with the prosthetic valve is delivered and deployed across the tricuspid valve between the RA and RV.

 Possible Indications for Procedure: Severe tricuspid regurgitation, usually secondary to left sided heart disease, pulmonary hypertension, RV dilation.

 Tricuspid valve surgery remains the highest surgical risk among all valve procedures and high operative mortality rates.

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving tricuspid valve therapies.

Tricuspid Valve: TTVI/TTVR: Key CPT Coding Points

 Included Components (Do Not Report Separately)

 Vascular access, catheterization

 Repositioning device and deployment

 Roadmapping angiography, RSI

 RA/RV angiography for completion of procedure

 Nondiagnostic heart catheterization

 Intracardiac Echocardiography (ICE)

 Temporary pacing

 Access site closure

 Separately Reportable Procedures

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

Tricuspid Valve: TTVI/TTVR: Key CPT Coding Points

 Separately Reportable Procedures

 Diagnostic Heart Catheterization Services

 Ventricular Support:

 Pump/Uptake Tube: 33975, 33976

 Percutaneous Ventricular Assist: 33990-33995

 IABP: 33967-33973

 Alternate TTVI/TTVR Option: TricValve by SingHealth

 An implant of two prosthetic valves in the superior and inferior vena cava (“Bicaval”) just outside of the RA. This is a lower risk option for patients who are not candidates for direct valve replacement either surgically or via a transcatheter approach.

 Consider coding this to unlisted procedure code 93799.

Tricuspid Valve : TTVI/TTVR : Medical Devices

 Transcatheter Tricuspid Valve

Implantation/Replacement Devices:

 TricValve by SingHealth

 Medtronic: Melody Valve (off label)

 Edwards LifeSciences: Sapien XT and 3 (off label)

 Cardiovalve Ltd: Cardiovalve

 Medtronic: Intrepid

 TRiCares: Topaz

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Transcatheter Tricuspid Valve

Implantation/Replacement Clinical Trials:

 Heterotopic Implantation Of the EdwardsSapien Transcatheter Aortic Valve in the

Inferior VEna Cava for the Treatment of Severe Tricuspid Regurgitation (HOVER): Henry Ford Health System: NCT02339974

 Surgical Treatment of Tricuspid Valve

Regurgitation in Patients With Cardiac

Implantable Electronic Devices: Long Term Results: NCT05774821

Tricuspid Balloon Valvuloplasty (TBV)

Tricuspid Valve : TBV: Code Set

 Tricuspid Balloon Valvuloplasty (TBV) CPT Code Range:

 93799: Unlisted cardiovascular service or procedure

Tricuspid Valve : TBV: CPT Procedure CPT Code Description/National Coverage Determination

 CPT Code Description

 Tricuspid Balloon Valvuloplasty first reported performance in 1986. No established CPT code exists for this procedure.

 Procedure Description: This code describes transcatheter delivery of a balloon to the tricuspid valve where the balloon is positioned across the valve and inflated to dilate the narrowed or blocked valve.

 Possible Indications for Procedure: Severe symptomatic tricuspid valve stenosis, either native or bioprosthetic in patients with need of immediate intervention not suitable for surgical or transcatheter valve replacement.

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving tricuspid valve therapies.

Tricuspid Valve : TBV: CPT Key Coding Points

 While no instructions exist from CPT, suggest following same rules for other established valvuloplasty codes.

 Included Components (Do Not Report Separately)

 Catheter placement

 RSI, Roadmapping, and imaging guidance to perform the procedure

 Nondiagnostic heart catheterization: for pressure gradient measurement

 Nondiagnostic Atrial/Ventricular angiography

 Hemostasis

 Separately Reportable Procedures

 Diagnostic heart catheterization and coronary angiography: 93451-93461

 TBV is a component of the following codes and cannot be reported separately:

 Transcatheter tricuspid valve implantation/replacement: 0646T

Tricuspid Valve : TBV: Medical Devices

 Transcatheter Tricuspid Valve Balloons

 Toray International America, INC: Inoue

 Transcatheter Tricuspid Valvuloplasty

Clinical Trials:

HCPCS Code for Facility Billing: C1725

 A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation: Shanghai Huihe Medical Technology Co., Ltd: NCT05770648

Transcatheter Tricuspid Valve Annulus Reconstruction

Tricuspid Valve : Transcatheter Tricuspid Valve Annulus Reconstruction :

Code Set

 Transcatheter Tricuspid Valve Annulus

Reconstruction CPT Code Range:

 0545T: Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach

Tricuspid Valve : Transcatheter Tricuspid Valve Annulus Reconstruction : CPT Procedure Code

Description/National Coverage Determination

 Procedure Description

 Code 0545T established in 2019

 Procedure Description: This code describes transcatheter delivery of an adjustable annulus ring. It is secured to annulus of the tricuspid valve by steel anchors. Once secured, the device is then contracted to reform the shape of the mitral valve, bringing the valve leaflets closer together. (Cardioband)

 Possible Indications for Procedure: Functional tricuspid regurgitation

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving tricuspid valve therapies.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare

Tricuspid Valve : Transcatheter Tricuspid Valve Annulus Reconstruction:

CPT Key Coding Points

 Included Components (Do Not Report Separately)

 Vascular access and catheterization

 Device deployment and adjustment

 Temporary pacing

 Access Site Closure

 Angiography, RSI, roadmapping inherent to device implant

 Ventriculography and completion angiography

 Nondiagnostic heart catheterization and angiography

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Diagnostic Heart Catheterization (Right and Left), and Coronary Angiography: 93451-93461

 Percutaneous Coronary Intervention: 92920-92944/C9600-C9608

Tricuspid Valve : Transcatheter Tricuspid Valve Annulus Reconstruction:

CPT Key Coding Points

 Separately Reportable Procedures:

 Cardiopulmonary Bypass Support: +33367- +33369

 Ventricular Support:

 Percutaneous Ventricular Assist: 33990-33995

 IABP: 33967-33973

Tricuspid Valve: Transcatheter Tricuspid Valve Annulus Reconstruction:

Medical Devices

 Transcatheter Tricuspid Valve Annulus

Reconstruction Devices

 Edwards LifeSciences: Cardioband

 Other devices that have unknown status:

TriCinch, Trialign

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Transcatheter Tricuspid Valve Annulus

Reconstruction Clinical Trials

 TRI-REPAIR: TrIcuspid Regurgitation

RePAIr With CaRdioband Transcatheter

System (TRI-REPAIR): Completed:

Edwards LifeSciences: NCT02981953

 Transcatheter Repair of Tricuspid

Regurgitation With Edwards

Cardioband TR System Post Market

Study (TriBAND) (TriBAND): NCT03779490

Transcatheter Tricuspid Valve

Repair/Transcatheter Edge to Edge Repair (TMVr/TEER)

Tricuspid Valve : TTVr/TEER: Code Set

 Transcatheter Tricuspid Valve

Repair/Transcatheter Edge to Edge Repair (TTVr/TEER):

 0569T: Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis

 0570T: Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session (List separately in addition to code for primary procedure)

Tricuspid Valve : TTVr/TEER: CPT Procedure Code Description/National Coverage Determination

 Procedure Description

 Code 0569T, 0570T created in 2020.

 Procedure Description: From the access point a catheter is delivered to the tricuspid valve where a clip(s) is attached to the edges of multiple leaflets to join them back together (Triclip, PASCAL ACE), (TEER)

 Possible Indications for Procedure: Tricuspid regurgitation

 National Coverage Determination

 No National Coverage Determination currently exists

 No requirement for registry data collection. The American College of Cardiology/Society of Thoracic Surgeons TVT Registry tracks data on patients receiving tricuspid valve therapies.

 Coverage for Category III CPT codes is limited and may or may not be covered by Medicare

Tricuspid Valve : TTVr/TEER: CPT Key Coding Points

 Included Components (Do Not Report Separately)

 Vascular access and catheterization

 Device deployment and adjustment

 Temporary pacing: 33210

 Access Site Closure

 Angiography, RSI, roadmapping inherent to device implant

 Intracardiac Echocardiography: 93662

 Nondiagnostic heart catheterization and angiography

 Separately Reportable Procedures:

 Transesophageal Echocardiographic Guidance (TEE): 93355

 Facility Coding: Apply modifier XU/59

 Professional Fee Coding: May not be billed by primary procedure operating physician

 Diagnostic Heart Catheterization (Right and Left), and Coronary Angiography: 9345193461

 Percutaneous Coronary Intervention: 92920-92944/C9600-C9608

Tricuspid Valve : TTVr/TEER: CPT Key Coding Points

 Separately Reportable Procedures:

 Cardiopulmonary Bypass Support: +33367- +33369

 Ventricular Support:

 Percutaneous Ventricular Assist: 33990-33995

 IABP: 33967-33973

Tricuspid Valve : TTVr/TEER: Medical Devices

 Transcatheter Tricuspid Valve

Repair/Transcatheter Edge to Edge

Repair (TTVr/TEER)

 Edwards Lifesciences: PASCAL Ace

 Abbott: TriClip

HCPCS Code for Facility Billing: No HCPCS Code, list device with revenue code 278 or 624

 Transcatheter Tricuspid Valve Annulus

Reconstruction Clinical Trials

 TRILUMINATE Study With Abbott

Transcatheter Clip Repair System in Patients With Moderate or Greater TR

(TRILUMINATE): Abbott:

NCT03227757

 The CLASP Study Edwards PASCAL

TrAnScatheter Mitral Valve RePair

System Study (CLASP): Edwards

LifeSciences: NCT03170349