ModifiedUnitedHealthcarePolicy CS123NJ.R

Transcatheter Procedures for Heart Valve Conditions (New Jersey)

Criteria and coverage guidance for transcatheter valve procedures (TAVR, TMVR, transcatheter mitral/tricuspid/pulmonary repairs/replacements and related devices) applicable to UnitedHealthcare members in New Jersey.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (New Jersey)

Policy CodePolicy CS123NJ.R

Change TypeModified — added TEER tricuspid criteriadocumentation clarifications

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain and submit medical records and diagnostic documentation to support that the individual meets the clinical criteria for the requested transcatheter valve procedure.

SourceLink

POLICY UPDATE CHANGES

Transcatheter edge-to-edge repair of the tricuspid heart valve is proven and medically necessary when used according to FDA labeled indications and the individual meets specified clinical criteria.

Replaced language that grouped repair, reconstruction, or replacement as unproven and not medically necessary with language that reconstruction or replacement is unproven and not medically necessary (preserving repair/TEER as covered when criteria met).

Medical records documentation may be required to assess whether the member meets the clinical criteria for coverage but does not guarantee coverage.

Definition of 'Symptomatic Severe Tricuspid Regurgitation' was added.

Supporting information (Description of Services, Clinical Evidence, FDA, and References) was updated to reflect current information.

Added language that benefit coverage is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service.

New JerseyApplies to

Yes

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

>=30dGDMT requirement

PROM ≥8%PROM threshold

Mean ≥40TAVR hemodynamics

CS123NJ.QPrevious version

Coverage Criteria for Transcatheter Valve Procedures

Aortic (TAVR) — Medically Necessary

Transcatheter aortic valve replacement (TAVR) is covered when ALL of the following are met:

Aortic TAVR initial criteria: Diagnosis of severe calcific native aortic valve stenosis evidenced by mean aortic valve gradient ≥ 40 mmHg OR peak aortic jet velocity ≥ 4.0 m/s OR aortic valve area ≤ 1.0 cm2; individual is symptomatic (NYHA Class II or greater) with symptoms due to aortic stenosis; an interventional cardiologist and an experienced cardiothoracic surgeon have determined the procedure is appropriate; individual has engaged in Shared Decision-Making with those clinicians; procedure performed in a center with on-site heart valve surgery and interventional cardiology programs, a post-procedure ICU experienced in valve patients, and meeting CMS volume/registry participation requirements; performed according to FDA labeled indications, contraindications, warnings, and precautions.Mean gradient ≥ 40 mmHg OR peak velocity ≥ 4.0 m/s OR AVA ≤ 1.0 cm2

Center and team requirements per policy; see CMS/STS/ACC guidance.

Aortic valve-in-valve (ViV) — Medically Necessary (high/prohibitive risk)

Transcatheter valve-in-valve (ViV) within a failed bioprosthetic aortic valve is covered when ALL of the following are met:

Aortic ViV: Individual is at high or prohibitive surgical risk defined by Predicted Risk of Mortality (PROM) score ≥ 8%; procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.PROM ≥ 8%

ViV TAVR evidence strongest in high/prohibitive risk aortic bioprosthesis failure; consider anatomical factors and device selection.

Mitral edge-to-edge repair — Primary MR

Transcatheter edge-to-edge mitral repair (e.g., MitraClip) is covered when ALL of the following are met for primary (degenerative) MR:

Primary (degenerative) MR criteria: Moderate-to-severe or severe MR (grade ≥ 3); symptomatic NYHA class III or IV; prohibitive surgical risk defined by either PROM ≥ 8% if likely to require replacement, PROM ≥ 6% if likely to undergo repair, or predicted risk of death or major morbidity at 1 year > 50%; care directed by a multidisciplinary heart team including a heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral disease; procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.PROM thresholds as above

Anatomic suitability and heart-team evaluation required.

Mitral edge-to-edge repair — Secondary MR

Transcatheter edge-to-edge mitral repair is covered for secondary (functional) MR when ALL of the following are met:

Secondary (functional) MR criteria: Moderate-to-severe or severe MR (grade ≥ 3) with left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%; symptomatic NYHA class II–IV (ambulatory); on optimal evidence-based management including guideline-directed medical therapy and cardiac resynchronization therapy as indicated; high surgical risk (PROM ≥ 8%); care directed by a multidisciplinary heart team including a heart failure specialist, interventional cardiologist, and cardiothoracic surgeon experienced in mitral disease; procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.LVEF 20–50%, PROM ≥ 8%

Document prior optimization of medical therapy and CRT as applicable.

Pulmonary valve replacement — Medically Necessary

Transcatheter pulmonary valve replacement is covered when ALL of the following are met:

Pulmonary indications: Right ventricular outflow tract (RVOT) dysfunction with moderate or greater pulmonary regurgitation and/or pulmonary stenosis with mean RVOT gradient ≥ 35 mmHg; procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.Mean RVOT gradient ≥ 35 mmHg

Document RVOT anatomy, prior conduit/valve details, and symptom/hemodynamic impact.

Tricuspid edge-to-edge repair — Medically Necessary (TEER)

Transcatheter tricuspid edge-to-edge repair (TEER) is covered when ALL of the following are met:

Tricuspid edge-to-edge repair criteria: Symptomatic Severe Tricuspid Regurgitation; receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure; symptomatic NYHA class II or greater; pulmonary artery systolic pressure (PASP) < 70 mmHg; intermediate or greater surgical risk as determined by the local multidisciplinary heart team (including cardiac surgery, interventional cardiology, echocardiography, and heart failure specialists); procedure performed according to FDA labeled indications, contraindications, warnings, and precautions.GDMT ≥ 30 days; NYHA ≥ II; PASP < 70 mmHg

Local heart team assessment and documentation required; medical records may be requested to verify criteria.

TAVR — Covered with criteria

Evidence-supported coverage considerations for TAVR

TAVR comparative evidence: Randomized controlled trials and meta-analyses demonstrate TAVR reduces or is noninferior to surgical aortic valve replacement (SAVR) for all-cause mortality and stroke up to 2 years across surgical risk spectra (high, intermediate, low) in multiple RCTs and meta-analyses.

References include PARTNER, CoreValve, SURTAVI, Evolut, PARTNER 3 and pooled analyses.

TAVR risks: TAVR is associated with higher rates of permanent pacemaker implantation and vascular complications but lower rates of major bleeding, new-onset atrial fibrillation, and acute kidney injury compared with SAVR.

Balance risks and benefits when selecting therapy; see pooled trial and registry data.

TAVR registry outcomes: Registries report high procedural success (approximately 91–99%), low procedural mortality, and variable 30-day and 1-year survival depending on device and approach.

Contemporary registry outcomes (SAPIEN 3, etc.) demonstrate favorable short-term hemodynamics and survival.

Bicuspid Aortic Valve — Conditional coverage

Bicuspid aortic valve considerations

BAV: Evidence is primarily observational; surgery remains first-line for most BAV patients. TAVR with latest-generation devices may be considered for patients with increased surgical risk when anatomy and device selection are suitable and performed at experienced centers.

Anatomic selection and use of contemporary devices required; limited RCT evidence exists.

TMVR — Limited/experimental stance

Transcatheter mitral valve replacement (TMVR) — limited/experimental stance

TMVR evidence: Insufficient high-quality evidence demonstrates long-term efficacy of TMVR. Existing data are largely observational or single-arm registries with short follow-up, high attrition, and noncomparative designs; comparative analyses suggest higher early mortality versus TEER and no mortality benefit versus guideline-directed medical therapy in some studies.

Requests for TMVR should include detailed patient-specific justification, registry/trial data, and heart-team assessment.

BAV considerations

Bicuspid aortic valve — surgical vs transcatheter considerations

BAV - when TAVR may be reasonable: TAVR may be a reasonable alternative in bicuspid aortic valve patients with increased surgical risk when using contemporary devices and careful anatomic selection; however, surgery remains first-line for the majority of BAV anatomies due to limited RCT evidence and potential anatomic challenges.

Heart-team evaluation and documentation of rationale required.

TMVR — evidence and limitations

Transcatheter mitral valve replacement (TMVR) — evidence and limitations

TMVR general stance: Evidence is insufficient to establish long-term efficacy of TMVR; most data are observational with limitations including noncomparative designs, short follow-up, and substantial attrition.

Comparative studies suggest no clear mortality benefit vs GDMT and potential higher early mortality vs TEER.

TMVR observed outcomes in registries: Registries report high technical success (e.g., ~95%) and durable MR reduction in many patients but variable mortality (e.g., 38.1% at 2 years in select cohorts) and significant adverse events in high-risk populations.

Patient selection and specialized center experience important for outcomes.

TEER — covered with criteria

Transcatheter edge-to-edge mitral valve repair (TEER) — evidence summary and coverage considerations

TEER efficacy — secondary MR: High-quality evidence (COAPT) demonstrates TEER plus medical therapy reduces heart-failure hospitalizations and mortality versus medical therapy alone in selected patients with secondary MR refractory to optimized GDMT; other trials (e.g., MITRA-FR) had neutral results likely due to differences in patient selection. Device-specific trials (eg, PASCAL CLASP IID) show noninferiority to MitraClip for key endpoints.

Appropriate patient selection and heart-team deliberation required.

TEER practical implications: TEER demonstrates safety and clinical benefit in selected high surgical-risk patients; registry data show high procedural success but variable residual MR and potential need for reintervention.

Anatomic suitability and functional status influence outcomes.

Percutaneous annuloplasty — limited evidence

Percutaneous annuloplasty and related devices — limited evidence

Percutaneous annuloplasty stance: Evidence quality is insufficient to draw definitive conclusions; randomized and observational studies show improvements in MR grade and functional status in some patients but are limited by small size, attrition, and lack of comparisons with other transcatheter or surgical options.

Consider use in clinical trials or select patients; not routinely interchangeable with established therapies.

Investigational/early-stage mitral devices — limited evidence

Early-stage devices: Several novel minimally invasive mitral repair devices (eg, Harpoon, Cardioband, NeoChord) show promising early results but require larger prospective studies with long-term follow-up before broad adoption; evidence currently limited to case series and single-group registries.

Consider investigational status and limited approvals for some products.

Pulmonary valve — favorable short/mid-term, uncertain long-term

Transcatheter pulmonary valve therapies — coverage considerations

Pulmonary valve outcomes: Single-arm and registry studies report favorable short- and mid-term outcomes (high device success, low early mortality) for devices such as SAPIEN 3, Harmony, and Alterra, but long-term durability and comparative effectiveness versus surgery remain uncertain.

Document device type, RVOT anatomy, prior conduit/valve details, and symptomatic/hemodynamic impact when requesting coverage.

Coverage stance by procedure

Coverage stance by procedure — device- and indication-specific considerations

T-TEER coverage logic: T-TEER (eg, TriClip) demonstrated reductions in TR severity, improved quality of life and functional status versus medical therapy in randomized trials (TRILUMINATE); coverage appropriate when patient has symptomatic moderate-or-greater TR despite optimal medical therapy and anatomy suitable for T-TEER as assessed by a heart team.

Longer-term mortality benefit not clearly established; patient selection critical.

TTVR coverage logic: TTVR (eg, EVOQUE) randomized data (TRISCEND II) show improvements in TR severity, QoL and functional metrics but with higher rates of severe bleeding and pacemaker implantation; consider coverage for patients with severe symptomatic TR who are not candidates for repair or surgery and meet device-specific selection criteria.

Longer-term safety and comparative data remain limited.

TPVI coverage logic: Transcatheter pulmonary valve implantation (Melody, SAPIEN, Harmony) demonstrates high procedural success and symptomatic/hemodynamic improvement in selected patients with RVOT conduit dysfunction or pulmonary regurgitation; coverage appropriate when established anatomic and clinical criteria are met and contraindications (eg, coronary compression risk) are excluded.

CAVI — evidence summary and insufficient long-term data

Caval Valve Implantation (CAVI) — evidence summary and limitations

CAVI evidence limitations: Available studies are small, open-label, and short-term; randomized data (TRICAVAL) showed no superior functional outcome and had safety concerns including valve dislocations prompting early termination; larger prospective studies with longer follow-up are needed before routine coverage.

Considered investigational outside of well-controlled research settings.

Valve-in-Valve (ViV) procedures — aortic and non-aortic evidence variability

Valve-in-Valve (ViV) procedures — evidence varies by valve position

Aortic ViV evidence: Observational studies and registry analyses show aortic ViV TAVR in high-risk/inoperable patients yields favorable early outcomes with similar or lower early mortality versus redo SAVR, but may have higher post-procedure gradients and worse hemodynamics in some subgroups; randomized trials are lacking and redo SAVR may be preferred in low-risk patients for superior hemodynamics.

Appropriate for high/prohibitive surgical risk when performed at experienced centers.

Non-aortic ViV evidence: Evidence for mitral, pulmonary, and tricuspid ViV is primarily observational, with promising short-term technical success but limited long-term comparative data; consider ViV in high-risk or inoperable patients with careful heart-team assessment.

Documentation of surgical risk and anatomic suitability recommended.

Cerebral Protection during TAVR — coverage stance with mixed evidence

Cerebral protection during TAVR — mixed evidence and coverage stance

RCT evidence: A large randomized trial (Kapadia et al., Sentinel device; n=3000) did not demonstrate a statistically significant reduction in periprocedural stroke within 72 hours or before discharge with cerebral embolic protection (CEP); disabling stroke was numerically lower but inconclusive.

Results apply to the Sentinel device and may not generalize to other devices.

Supportive but inconclusive data: Smaller RCTs and meta-analyses show reductions in lesion volume or number on DW-MRI and mixed clinical signals, but limitations (small size, surrogate imaging endpoints, missing follow-up) prevent routine coverage for all patients; NICE recommends use only with special governance arrangements.

Routine use not established — consider case-by-case or research settings.

Guideline-based indications and considerations

Guideline-based indications and considerations that inform coverage decisions

Aortic valve TAVR/ViV considerations: Choice between TAVR and SAVR should be individualized by the heart team; TAVR reasonable in older or high-risk patients and may be considered in selected BAV patients when performed at Comprehensive Valve Centers.age/sts risk thresholds referenced

See ACC/AHA/ESC/STS guidelines for specific risk thresholds and center requirements.

Mitral transcatheter repair: Transcatheter edge-to-edge repair is reasonable in high/prohibitive surgical risk symptomatic primary MR patients with favorable anatomy and life expectancy ≥ 1 year; for chronic secondary MR, TEER is reasonable for appropriately selected patients with LVEF 20–50%, LVESD ≤ 70 mm, and PASP ≤ 70 mmHg on optimal therapy.LVEF 20–50%, LVESD ≤ 70 mm, PASP ≤ 70 mmHg

Guideline criteria should guide patient selection.

Pulmonary and congenital RVOT interventions:

Cerebral protection evidence synthesis

Cerebral protection evidence synthesis — detailed items informing coverage assessment

Imaging endpoint trials: Two randomized trials did not meet primary DW-MRI imaging endpoints and had substantial missing imaging follow-up, limiting conclusions about clinical benefit of embolic protection during TAVR.

Surrogate imaging endpoints do not confirm clinical stroke reduction.

CLEAN-TAVI findings: A small RCT (CLEAN-TAVI; n=100) showed reduced number and volume of new ischemic lesions with cerebral protection but lacked sufficient size and clinical outcome data to establish benefit.

Hypothesis-generating; larger trials required.

Meta-analysis conclusions: Systematic reviews of RCTs (eg, 4 RCTs, n=252) found lower lesion volume and number with embolic protection but no significant reduction in stroke or mortality; results are limited by trial quality and heterogeneity.

Further adequately powered RCTs are needed.

NICE guidance–conditioned coverage

NICE guidance–conditioned coverage and special arrangements

NICE-supported uses with governance: NICE supports select transcatheter valve procedures (eg, ViV TAVR for aortic bioprosthetic dysfunction, certain mitral leaflet repairs, and cerebral protection during TAVR) only when accompanied by arrangements for clinical governance, informed consent, audit, or research due to limited or variable evidence quality.

Use in the context of governance and data collection as advised by NICE.

Tricuspid edge-to-edge repair (TEER) - Medically necessary criteria

Covered when ALL of the following are met

Tricuspid TEER coverage criteria: 1) Symptomatic Severe Tricuspid Regurgitation (TR); 2) Receiving stable (≥ 30 days) guideline-directed medical therapy (GDMT) for heart failure; 3) Symptomatic NYHA class II or greater; 4) Pulmonary artery systolic pressure (PASP) < 70 mmHg; 5) Intermediate or greater risk for surgery as determined by the local multidisciplinary heart team (including cardiac surgery, interventional cardiology, echocardiography, and heart failure specialists); and 6) Procedure to be used according to FDA labeled indications, contraindications, warnings, and precautions.GDMT ≥ 30 days; NYHA ≥ II; PASP < 70 mmHg

This coverage set reflects newly added material in the policy update; medical records documentation may be required to verify criteria and does not guarantee coverage.

Transcatheter mitral procedures other than transcatheter edge-to-edge repair (TEER) — such as percutaneous annuloplasty, transcatheter mitral annulus reconstruction, or other mitral reconstruction techniques — are identified in the policy as having insufficient evidence to demonstrate efficacy. The policy states that TEER (e.g., MitraClip) is proven and medically necessary when used according to FDA labeled indications and specified clinical criteria, but explicitly notes that other transcatheter mitral repair approaches and transcatheter mitral reconstruction or replacement are unproven and not medically necessary due to limited quality evidence.

The policy emphasizes that surgical aortic valve replacement remains first-line for most patients with bicuspid aortic valve (BAV). While observational and registry data suggest TAVR with newer-generation devices may be a reasonable alternative in selected patients with increased surgical risk, the document notes randomized trial evidence is lacking and that surgery is generally preferred for the majority of BAV anatomies.

Although the excerpt does not list broad categorical exclusions, it makes clear that transcatheter mitral valve replacement (TMVR) and percutaneous annuloplasty lack sufficient high-quality comparative evidence to be considered equivalent to established surgical or edge-to-edge transcatheter options. Requests for these procedures therefore require patient-specific justification and supporting data; absent that, they may be considered investigational or not medically necessary.

Caval valve implantation (CAVI) is described as having insufficient high-quality, long-term evidence and notable safety concerns in limited randomized data (for example, valve dislocations in TRICAVAL). Because of small study sizes, short follow-up, and safety signals, CAVI procedures may be excluded or subject to restricted use pending more robust evidence.

The policy states that procedures for which long-term safety and efficacy data are lacking should be treated as experimental or investigational. Examples in this excerpt include CAVI, non-aortic ViV procedures (mitral/pulmonary/tricuspid), and routine use of cerebral embolic protection during TAVR, all of which are noted to require stronger prospective evidence before routine coverage is appropriate.

For aortic regurgitation the document notes there is no currently accepted transcatheter intervention. This means transcatheter alternatives for isolated aortic regurgitation are not supported by the evidence summarized in the policy excerpt.

The policy lists several products that may not have full FDA approval (for example, Cardioband, Carillon, Harpoon, Intrepid, NeoChord, Tiara, TricValve, TriGUARD 3) and notes that such devices may be considered investigational or limited use. TMVR overall is also described as having insufficient long-term efficacy evidence, reinforcing that some devices and procedures require special consideration or trial-based use.

Transcatheter tricuspid reconstruction or orthotopic replacement devices (TTVR) are described as having limited long-term evidence. While some randomized and registry data show symptom and quality-of-life improvements, early safety signals and incomplete longer-term follow-up mean that tricuspid reconstruction or replacement outside of defined trial settings or selected populations may be considered unproven and not medically necessary.

The policy makes clear that documentation demonstrating a member meets the clinical criteria does not automatically guarantee coverage. Benefit determinations are subject to federal, state, or contractual requirements and applicable laws, and the member’s medical record must fully support medical necessity; documentation may be requested and coverage remains contingent on applicable benefit terms.

Exceptions for transcatheter mitral valve repair or replacement are narrowly defined: edge-to-edge mitral repair (TEER) is proven and medically necessary when FDA labeled indications and the policy criteria are met, whereas transcatheter mitral repair techniques other than edge-to-edge and TMVR are considered unproven or investigational except where specific, well‑documented indications and supporting evidence justify their use.

The policy states that TMVR should not be considered a routine alternative to surgical repair or TEER because current evidence is insufficient—observational series show high technical success but also substantial intermediate-term mortality and limited comparative benefit versus guideline-directed medical therapy or TEER.

Because TMVR and percutaneous annuloplasty data are primarily noncomparative, limited in size, and have short follow-up or high attrition, the policy requires that requests include detailed anatomic characterization, registry or trial data when available, prior therapies attempted, and surgical risk assessment. Absent adequate documentation, these procedures may be considered not medically necessary.

TTVR and other tricuspid replacement devices report early improvements in TR severity and functional status in some studies, but the policy notes insufficient long-term, high-quality evidence. Because of early safety concerns and limited follow-up, use of these devices outside clinical trials or highly selected populations may be restricted.

The routine use of caval valve implantation (CAVI) and routine deployment of cerebral protection devices during TAVR is not supported by conclusive long-term evidence. The policy indicates these uses may be considered not medically necessary or investigational due to small studies, early safety issues (for CAVI), and mixed randomized trial results for cerebral embolic protection.

Large randomized evidence has not established clinical benefit for routine cerebral embolic protection during TAVR. Two DW‑MRI imaging endpoint trials did not meet primary endpoints and a large RCT of the Sentinel device (n=3,000) found no significant reduction in periprocedural stroke; meta-analyses show reduced lesion volume without definitive stroke or mortality benefit. Therefore, routine use of cerebral embolic protection is not established as medically necessary based on current trial outcomes.

The policy reiterates that transcatheter tricuspid reconstruction or orthotopic tricuspid valve replacement is unproven and not medically necessary outside the specific circumstances where edge-to-edge tricuspid repair meets the listed criteria; long‑term safety and efficacy data for replacement devices remain limited.

Procedure and Product Codes

Specified T/CPT Codes (part 1)CPT

0345T	Transcatheter mitral valve repair percutaneous approach via the coronary sinus.
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).
0543T	Transapical mitral valve repair, including transthoracic echocardiography, when performed, with placement of artificial chordae tendineae.
0544T	Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture.
0545T	Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach.
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).
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.
0805T	Transcatheter superior and inferior vena cava prosthetic valve implantation (i.e., caval valve implantation [CAVI]); percutaneous femoral vein approach.

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Specified T/CPT Codes (part 2)CPT

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).
33367	TAVR with cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (List separately).
33368	TAVR with cardiopulmonary bypass support with open peripheral arterial and venous cannulation (List separately).
33369	TAVR with cardiopulmonary bypass support with central arterial and venous cannulation (List separately).
33370	Transcatheter placement and subsequent removal of cerebral embolic protection device(s), percutaneous (List separately).

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NJ Medicaid fee schedule notesmixed

* (asterisked codes)

Codes labeled with an asterisk are not on the State of New Jersey Medicaid Fee Schedule and may not be covered by New Jersey Medicaid.

Codes not present in this excerptmixed

No codes listed

Device PMA/Reference Codesmixed

P130021	PMA reference listing Evolut FX/PRO/R
P190023	PMA reference listing Navitor
P140031	PMA reference listing SAPIEN 3 series
P100009	PMA reference listing MitraClip
P220003	PMA reference listing PASCAL
P200046	PMA reference listing Harmony (pulmonary)
P140017	PMA reference listing Melody
P200015	PMA reference listing SAPIEN 3 (pulmonary) and Alterra
P230013	PMA reference listing EVOQUE (tricuspid)
P230007	PMA reference listing TriClip

Cerebral protection product codemixed

PUM	Product code for cerebral embolic protection devices (De Novo/510(k) searches; e.g., SENTINEL)

Additional products (limited/unclear approval)neutralExperimental

List of additional products that may not have full FDA approval: Cardioband, Carillon, Harpoon, Intrepid, NeoChord, Tiara, TricValve, TriGUARD 3

Aortic stenosis hemodynamic thresholds

Mean aortic valve gradient≥ 40 mmHg

Peak aortic jet velocity≥ 4.0 m/s

Aortic valve area (AVA)≤ 1.0 cm2

PROM thresholds (STS PROM)

PROM for high/prohibitive surgical risk≥ 8% (used to define high/prohibitive surgical risk for aortic ViV and for individuals likely to undergo mitral valve replacement)

PROM for likely mitral repair

Prior Authorization, Documentation, and Authorization Guidance

Prior Authorization

Prior Authorization Required for Listed Procedure Codes

Prior authorization is required for listed transcatheter valve procedure codes. Providers should request prior authorization before scheduling procedures and confirm the specific CPT/TAR codes are included in the authorization. Note that some codes marked with an asterisk (*) may not be covered under New Jersey Medicaid and prior authorization does not guarantee payment.

Affected codes include (but are not limited to): 0345T, 0483T, 0484T, 0543T, 0544T, 0545T, 0569T, 0570T, 0646T, 0805T, 0806T, 33361-33370 series, 33418-33419, 33477, 93799, 0646T, 0805T, 0806T
Codes labeled with an asterisk (*) are not on the NJ Medicaid Fee Schedule and may not be covered

Prior Authorization

Device-Specific Prior Authorization Necessity

Some devices and device-specific procedures commonly require prior authorization and inclusion of the device identifier or descriptor in the authorization request. When applicable, list the device model, regulatory pathway (PMA/510(k)/De Novo), and device identifier to facilitate review.

Provide device trade name and model (eg, EVOQUE, TRISCEND II devices, SAPIEN 3, Evolut, MitraClip)

Background and Description of Services

Background: Transcatheter valve procedures are catheter-based alternatives to open-heart surgical repair or replacement for diseased heart valves (aortic, mitral, tricuspid, pulmonary). These interventions use prosthetic valves or repair devices delivered via vascular or minimally invasive approaches to restore valve function without cardiopulmonary bypass. Indications differ by valve position and are influenced by surgical risk, hemodynamics, symptoms, and device-specific evidence.

Definitions and Clinical Terms

NYHA classification

NYHA Class INo limitation of physical activity; ordinary activity does not cause symptoms

NYHA Class IISlight limitation; comfortable at rest, ordinary activity causes fatigue or dyspnea

NYHA Class IIIMarked limitation; less than ordinary activity causes symptoms

NYHA Class IVUnable to carry on any physical activity without discomfort; symptoms at rest

PROM (STS Predicted Risk of Mortality)

DefinitionPROM (STS Predicted Risk of Mortality) is a predictor of 30-day mortality after cardiac procedures

Use

Policy Revision History and Summary of Changes

2026-01-01Criteria addedLatest

Added coverage criteria establishing transcatheter edge-to-edge repair (TEER) of the tricuspid valve as proven and medically necessary when used per FDA labeling and specified clinical criteria (including symptomatic severe TR, ≥30 days stable GDMT, NYHA II+, PASP <70 mmHg, and intermediate-or-greater surgical risk determined by a multidisciplinary heart team).

2026-01-01Policy language revised

Revised prior language that grouped repair, reconstruction, or replacement as unproven to clarify that reconstruction or replacement remain unproven and not medically necessary while preserving repair/TEER as covered when criteria are met.

Policy Summary

PayerUnitedHealthcare

PolicyTranscatheter Procedures for Heart Valve Conditions (New Jersey)

Policy CodePolicy CS123NJ.R

Change TypeModified — added TEER tricuspid criteriadocumentation clarifications

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain and submit medical records and diagnostic documentation to support that the individual meets the clinical criteria for the requested transcatheter valve procedure.

SourceLink

On This Page

Prestenting and device-specific considerations affect outcomes.

CAVI coverage logic: Caval valve implantation (CAVI) evidence is limited to small, short-term studies with heterogeneous devices and trial signals of safety concerns (eg, valve dislocations in TRICAVAL); consider investigational or limited coverage pending stronger evidence and device-specific outcomes.

Randomized data are sparse and safety signals warrant caution.

Transcatheter pulmonary valve replacement and stenting are alternatives to surgery for RVOT conduit dysfunction and may improve hemodynamics and exercise capacity; consider when technically feasible and indicated.

clinical symptoms or conduit dysfunction

Refer to congenital heart disease and RVOT guidance.

Tricuspid interventions: Transcatheter treatments for tricuspid regurgitation have weaker evidence (IIb) and may be considered in inoperable/high-risk patients at specialized centers following heart-team evaluation.symptomatic severe TR, inoperable or high surgical risk

Specialized center experience recommended.

Valve-in-valve: Transcatheter ViV implantation is reasonable for bioprosthetic aortic dysfunction in high or prohibitive surgical risk patients when performed at Comprehensive Valve Centers; mitral and tricuspid ViV have IIb recommendations and are considered in selected high-risk patients.high/prohibitive surgical risk

Document PROM/STSprom and heart-team rationale.

NICE stance on cerebral protection: NICE states evidence on efficacy for preventing TAVR-related stroke is inconclusive and recommends use only with special arrangements for governance, consent, and audit or research.

Consider governance and audit if used per NICE guidance.

≥ 6% (used when individuals are deemed likely to undergo mitral valve repair)

PROM purposeSTS Predicted Risk of Mortality (PROM) estimates 30-day surgical mortality and is used to stratify operative risk

Pulmonary RVOT gradient

Mean RVOT gradient threshold≥ 35 mmHg

Indication contextApplies to pulmonary valve replacement for RVOT dysfunction with moderate or greater pulmonary regurgitation and/or pulmonary stenosis

Source study noteReferenced in device/registry eligibility criteria and pivotal studies (see pulmonary section)

Pulmonary artery systolic pressure limit for tricuspid repair

PASP eligibility limit for tricuspid TEER< 70 mmHg

ContextRequired threshold within tricuspid edge-to-edge repair coverage criteria (policy update)

AssessmentPulmonary artery systolic pressure should be assessed by the treating heart team prior to procedure

Stable guideline-directed medical therapy (GDMT)

Minimum stable GDMT duration>= 30 days

ApplicabilityRequired for individuals considered for transcatheter tricuspid edge-to-edge repair

DocumentationMedical records should document duration and optimization of guideline-directed medical therapy

Pulmonary artery systolic pressure (PASP) threshold

PASP eligibility value< 70 mmHg

Procedure contextListed as an eligibility requirement for transcatheter tricuspid edge-to-edge repair

Assessment noteMeasured PASP should be included in documentation submitted for authorization

Symptom severity requirement

Required symptom severityNYHA class II or greater

Definition sourceNYHA classification describes limits of physical activity across classes I–IV

Clinical contextSymptom class must be attributable to valve disease (eg, TR) per local heart team assessment

State FDA regulatory status (PMA, 510(k), De Novo) where known

Include any available trial/registry identifier or pivotal trial name to support clinical rationale

Documentation Required

Prior Authorization: ViV / TMVR Documentation Recommended

For valve‑in‑valve (ViV) and transcatheter mitral valve replacement (TMVR) requests, prior authorization should include detailed surgical risk assessment, indication for the procedure, and prior valve details. Submission of this documentation supports medical necessity review.

Document surgical risk using STS PROM (include numeric score) and heart‑team determination
Specify indication (stenosis vs regurgitation) and symptoms (NYHA class)
Provide prior valve information: original valve type, size, manufacturer, date of implantation, and reason for failure (stenosis, regurgitation, mixed)
Include prior interventions (redo SAVR considered or contraindicated) and rationale for transcatheter approach

Note

Prior Authorization Consideration for Transcatheter Procedures

Prior authorization may be requested for transcatheter valve procedures (TAVR, TMVR, TTVR, T-TEER, pulmonary valve interventions). FDA status is informational only; authorization decisions will consider clinical guidelines, available trial evidence, and the strength/limitations of published data.

Requests should reference relevant guideline recommendations and pivotal trial/registry evidence
FDA approval or PMA listing is not by itself sufficient for coverage — clinical criteria and evidence quality drive decisions

Prior Authorization

Device-Specific Prior Authorization — Include Regulatory Status and Device Identifiers

When devices are identified in an authorization request, indicate the device regulatory pathway and, when available, the unique device identifier or PMA/510(k)/De Novo citation. This expedites review and aligns the request with the supporting evidence base.

Include PMA/510(k)/De Novo status and, if available, the FDA accession or PMA ID
List full device name and manufacturer (eg, SAPIEN 3 — Edwards Lifesciences; Evolut — Medtronic; MitraClip — Abbott; SENTINEL — Boston Scientific)

Note

Prior Authorization — Not Specified Here (Operational Note)

If no explicit prior authorization requirement is listed for a specific code or scenario in this excerpt, providers should still consult the payer's Authorization Lookup or contact UnitedHealthcare Provider Services. Absence of a listed rule in this section does not mean prior authorization is not needed.

Check the payer’s current online authorization tools and member benefit plans
Submission of medical records may still be required even when a code is not explicitly listed

Denial Risk

Prior Authorization Requirement and Denial Risk Considerations

Authorization review will assess whether submitted documentation meets clinical criteria. Common denial risks include selection of an approach without adequate justification (for example, selecting TAVR/BAV over surgical repair when surgery is feasible), insufficient trial comparative evidence (eg, TMVR when TEER/GDMT not tried or unsuitable), or device contraindications.

Document rationale when choosing TAVR for bicuspid aortic valve (BAV) instead of surgery
For TMVR, document why less‑invasive proven alternatives (TEER/GDMT) are unsuitable or were attempted and failed
Report any anatomic or clinical contraindications that would preclude implantation (eg, coronary compression risk for pulmonary valve)

Note

Evidence Limitations and Supporting Clinical Outcome Data

Evidence limitations may affect authorization and coverage decisions. When available, include supporting clinical outcome data, trial identifiers, and follow‑up outcome measures to substantiate benefit and safety.

Provide procedural success rates, 30‑day and 1‑year mortality, stroke, readmission, and device‑specific outcomes where available
Cite registries/trials (eg, PARTNER, VIVID, TRISCEND II, TRILUMINATE, CHOICE‑MI) when relevant

Documentation Required

TMVR — Required Supporting Documentation for Prior Authorization

For TMVR and other newer mitral procedures, prior authorization should include specific supporting documentation: comparative evidence or justification if comparative trials are limited, anatomic characterization (imaging), registry/trial data when available, and planned follow‑up/outcome monitoring.

Submit echocardiographic measures (MR grade, valve gradients, LVEF), CT/planimetry as indicated, and procedural imaging plan
Provide registry or trial identifiers and available outcome data (technical success, MR reduction, NYHA change, mortality)
Document why alternative therapies (TEER, annuloplasty, GDMT, surgery) are unsuitable or have failed

Documentation Required

Neuroimaging and Follow‑Up Documentation

Neuroimaging and postoperative follow‑up documentation may be requested for procedures with known cerebral embolic risk. If cerebral protection devices are used or considered, include neurologic baseline and follow‑up plans and any DW‑MRI timing relevant to trial data.

Provide baseline neurologic assessment and planned postprocedure neuroimaging timing (eg, MRI at 48–72 hours if part of protocol) when applicable
Document use of cerebral embolic protection device and rationale; include device name and supporting evidence if relied upon for risk mitigation

Documentation Required

Governance and Consent Documentation for Novel/High‑Risk Procedures

When a procedure is performed under special arrangements (per NICE or other guidance), include documentation of clinical governance arrangements, informed consent that discusses limited evidence or novel risk profile, and plans for audit or research follow‑up.

Document that the procedure is performed with arrangements for governance, consent, and audit or research when indicated by guidance (eg, transapical TMViV per NICE)
Include signed informed consent that documents known limitations of evidence and alternative options

Note

Provide Source Publications, Guidelines, and References with Requests

References, guideline citations, and pivotal trial publications are used to support prior authorization and coverage decisions. Requests that reference up‑to‑date, relevant literature and guideline statements help expedite review.

Attach pertinent publications, guideline excerpts, and trial identifiers used to justify the request
Updated Description of Services, Clinical Evidence, FDA, and References sections have been incorporated into policy supporting information

Step Therapy

Therapy Sequencing and Documentation (GDMT and Less‑Invasive Options)

Therapy sequencing matters for coverage decisions. Prior authorization requests should document prior guideline‑directed medical therapy (GDMT), attempts at less‑invasive therapies (eg, TEER for mitral disease), and rationale for proceeding to more invasive transcatheter replacement when applicable.

Document duration and components of GDMT (eg, ≥30 days for TR prior to TTVR consideration)
State whether TEER or other less‑invasive options were considered or attempted and the clinical reasons they were unsuitable

Note

Policy Versioning, Archived Previous Policy Version, and Operational Note

This section includes policy history and archived material. The current policy (CS123NJ.R) supersedes archived versions (including CS123NJ.Q). Providers should rely on the current effective policy for authorization requirements and note that policy history entries document updates to documentation and supporting information but do not by themselves change authorization mechanics.

Archived previous policy version: CS123NJ.Q
Policy history documents updates to clinical criteria, documentation expectations, and supporting sections; consult current policy effective date 2026-01-01

Note

Policy History Contains Supporting Information — No New Actionable Triggers in Placeholders

Policy history and supporting information blocks contain multiple placeholders and update notes; they do not by themselves establish additional prior authorization criteria. Providers should not assume new procedural rules from policy history placeholders — consult the current policy text and payer authorization resources.

Many policy history entries are summaries or placeholders noting updates to Description of Services, Clinical Evidence, FDA, and References
No additional actionable denial triggers are specified solely in the history placeholders — clinical denial reasons are based on documented criteria and evidence gaps

Used to estimate surgical risk and to define high/prohibitive risk thresholds in coverage criteria (eg, PROM ≥ 8%)

SourceSociety of Thoracic Surgeons risk model (STS PROM) referenced in policy definitions

Shared Decision-Making (SDM)

DefinitionShared Decision-Making is a collaborative process between physicians and individuals to choose treatment reflecting clinical evidence and patient values

Policy roleRequired for TAVR and other transcatheter procedures per coverage criteria

ParticipantsTypically involves interventional cardiologist and experienced cardiothoracic surgeon for aortic procedures

Aortic stenosis

DefinitionAortic stenosis is narrowing/obstruction of the aortic valve that impairs leaflet opening and increases left ventricular workload

Clinical impactCan cause chest pain, dyspnea, fluid retention and progress to heart failure if severe and untreated

TAVR roleTAVR is a minimally invasive alternative to surgical replacement for severe aortic stenosis when criteria met

Transcatheter leaflet repair (edge-to-edge)

DefinitionTranscatheter leaflet repair (edge-to-edge) uses a clip delivered via a steerable guide catheter to approximate valve leaflets and reduce regurgitation

AccessTypically performed via transseptal puncture through the femoral vein for mitral procedures

Example devicesMitraClip, PASCAL are examples of edge-to-edge devices

Valve-in-valve

DefinitionValve-in-valve (ViV) is transcatheter implantation of a heart valve within a failed or degenerated previously implanted bioprosthetic valve

Common useMost commonly applied in the aortic position; evidence strongest for aortic ViV in high/prohibitive surgical risk patients

GuidanceNICE supports use with clinical governance and audit arrangements

TEER — definition and examples

DefinitionTEER (transcatheter edge-to-edge repair) approximates valve leaflets (eg, MitraClip, PASCAL) to reduce mitral regurgitation

Clinical applicationUsed in selected high surgical risk patients or per FDA-labeled indications; improves HF hospitalizations in COAPT trial

ExamplesMitraClip, PASCAL

MAC (mitral annular calcification)

DefinitionMitral annular calcification (MAC) is heavy calcification of the mitral annulus that complicates surgical and transcatheter interventions

Clinical relevanceMAC is associated with higher procedural complexity and risk in mitral interventions such as TMVR

Evidence noteTMVR data in severe MAC are limited and derived largely from registries and compassionate-use series

TPVI / PPVI

DefinitionTPVI / PPVI is percutaneous implantation of a bioprosthetic valve (eg, Melody, SAPIEN family, Harmony) into dysfunctional RVOT conduits or surgical pulmonary valves

IndicationsUsed for moderate-or-greater pulmonary regurgitation and/or pulmonary stenosis with elevated RVOT gradient

Device examplesMelody, SAPIEN 3, Harmony, Alterra

T-TEER

DefinitionT-TEER (transcatheter tricuspid edge-to-edge repair) uses leaflet-approximation devices (eg, TriClip, PASCAL) to reduce tricuspid regurgitation

Clinical contextStudied versus medical therapy; shown to reduce TR severity and HF hospitalizations in TRILUMINATE

Device examplesTriClip, PASCAL

TTVR — definition

DefinitionTTVR (transcatheter tricuspid valve replacement) is percutaneous orthotopic replacement of the tricuspid valve using dedicated replacement systems (eg, EVOQUE)

EvidenceRCT data (TRISCEND II/EVOQUE) show improvements in TR and functional outcomes but with notable bleeding and pacemaker risks; longer follow-up needed

Use caseConsidered for severe symptomatic TR in high surgical risk patients when repair is not feasible

CAVI — definition and evidence

DefinitionCAVI places a valve in the inferior or superior vena cava to reduce systemic venous regurgitation from severe TR when orthotopic therapy is not feasible

Evidence limitationsAvailable studies are small and short-term; randomized data (TRICAVAL) stopped early for valve dislocations and showed no superiority

Clinical roleConsidered investigational pending larger prospective studies

Caval Valve Implantation (CAVI) — duplicate

Duplicate definitionCaval valve implantation: transcatheter placement of a valve in the inferior or superior vena cava to treat severe TR by reducing caval reflux

Evidence noteSmall studies show symptomatic improvement but long-term efficacy and safety are uncertain

RecommendationUse only in research settings or with strong supporting evidence and governance

Valve-in-Valve (ViV) — definition

DefinitionValve-in-Valve (ViV) is transcatheter implantation of a valve inside a failed surgical bioprosthetic valve

Aortic ViV evidenceStrongest evidence exists for aortic ViV TAVR in high/inoperable-risk patients; observational data and registries support use

Non-aortic ViVEvidence for mitral, pulmonary, and tricuspid ViV is limited and primarily observational

Cerebral Embolic Protection (CEP)

DefinitionCerebral Embolic Protection (CEP) devices are deployed during TAVR to capture or deflect embolic debris to reduce periprocedural cerebral ischemic events

Clinical evidenceRCT evidence is mixed; a large RCT did not show significant reduction in periprocedural stroke (Kapadia et al., 2022)

Use recommendationNICE recommends use only with special arrangements for governance, consent, and audit or research due to inconclusive efficacy evidence

Cerebral embolic protection — duplicate

Duplicate definitionCerebral embolic protection devices aim to capture/deflect embolic debris during TAVR to reduce new ischemic cerebral lesions measured by DW-MRI

Evidence limitationsTwo small RCTs failed to meet primary DW-MRI endpoints; meta-analyses show reduced lesion volume but no definitive clinical stroke benefit

GuidanceNICE advises use only with special governance and audit due to inconclusive evidence

ViV TAVR — NICE commentary

Duplicate ViV definitionViV: transcatheter implantation of a prosthetic valve within a failing bioprosthetic surgical valve as an alternative to redo surgery in high-risk patients

NICE commentaryNICE states ViV TAVR for aortic bioprosthetic dysfunction is supported if governance, consent, and audit arrangements are in place; long-term data limited

Evidence contextObservational registries and meta-analyses inform current practice; randomized trials lacking

Symptomatic Severe Tricuspid Regurgitation — new definition

New definition addedSymptomatic Severe Tricuspid Regurgitation was added to the policy definitions (text present in Definitions section)

Clinical featuresIncludes valve hemodynamics (eg, central jet ≥ 50%, vena contracta ≥ 0.7 cm, EROA ≥ 0.40 cm2, regurgitant volume ≥ 45 mL) and right-sided dilation and symptoms

Policy noteDefinition supports coverage criteria for transcatheter tricuspid TEER introduced in the 01/01/2026 revision

Symptomatic Severe Tricuspid Regurgitation — note

Note on added definitionPolicy indicates a new definition was added for 'Symptomatic Severe Tricuspid Regurgitation' though full text may be located in Definitions section of policy

Revision contextDefined in the 01/01/2026 policy history entry accompanying coverage changes for tricuspid TEER

ImplicationSupports objective hemodynamic and symptom-based eligibility for TEER

Symptomatic Severe Tricuspid Regurgitation — definition added

Definition present in policy historySymptomatic Severe Tricuspid Regurgitation definition text was added to the policy (see Definitions and Supporting Information)

DocumentationDefinition underpins coverage criteria and required documentation expectations for TEER

Revision dateAdded during 01/01/2026 policy update

Symptomatic Severe Tricuspid Regurgitation — duplicate

Duplicate entrySymptomatic Severe Tricuspid Regurgitation definition appears multiple times in the policy revision/history sections

Clinical componentsIncludes hemodynamic criteria, right-sided dilation, elevated c-V wave, and relevant symptoms such as fatigue, abdominal bloating, peripheral edema

Use in criteriaReferenced as the primary diagnosis requirement for transcatheter tricuspid TEER coverage

Symptomatic Severe Tricuspid Regurgitation — duplicate

Repeated definition noteThe policy contains duplicate entries noting the addition of 'Symptomatic Severe Tricuspid Regurgitation' to Definitions

Policy implicationEnsures consistent application of TEER eligibility across documentation and prior authorization reviews

LocationSee Definitions and Policy History (01/01/2026) for supporting text

2026-01-01Documentation language added

Added medical records documentation expectations noting that documentation may be required to assess whether members meet clinical coverage criteria, must fully support medical necessity, include relevant history/exam and diagnostic results, be legible, and be made available upon request.

2026-01-01Definition added

Added a definition for 'Symptomatic Severe Tricuspid Regurgitation' to the Definitions section.

2026-01-01Supporting information updated

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.

Policy history: this policy replaces and archives the prior UnitedHealthcare New Jersey policy version CS123NJ.Q and documents revisions effective 01/01/2026. The revision history notes updates to tricuspid coverage rationale, supporting information (Description of Services, Clinical Evidence, FDA references), and additions clarifying medical records documentation expectations.

Policy history entries: multiple revision-history chunks document the 01/01/2026 updates, including addition of tricuspid TEER coverage criteria, replacement of prior language about tricuspid repair/replacement, clarification that medical records documentation may be required (but does not guarantee coverage), addition of a definition for 'Symptomatic Severe Tricuspid Regurgitation,' and updating of supporting sections (Clinical Evidence, FDA, References). Several archived entries reference the prior policy CS123NJ.Q.

Policy history details: the record contains multiple summary entries and placeholders noting supporting information updates and archival of previous versions. The history emphasizes documentation requirements (medical record must fully support medical necessity and be available on request) and that coverage decisions are governed by applicable federal, state, and contractual rules.

Policy history section: the document includes a dedicated Policy History section with multiple dated entries and summary-of-changes notes. These entries serve as the formal record of revisions and clarify that supporting information and definitions were updated in the current policy iteration.