Archived Policies - Surgery


Transcatheter Heart Valve Replacement

Number:SUR707.028

Effective Date:06-15-2011

End Date:10-14-2012

Coverage:

Transcatheter heart valve replacement (by any method) is considered experimental, investigational and unproven.

Description:

The heart has four chambers which receive and pump blood.  Blood flows through these chambers with the assistance of valves that open and close, serving as a gate.  A valve may be defective for many reasons, usually because it doesn’t open or close properly causing leaks or stenosis.  When the treating physician determines that a valve needs to be replaced, the most common treatment has traditionally been performed with open-heart surgery.  

Transcatheter heart valve replacement is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open-heart surgery.  PHV replacement is the delivery of a prosthetic heart valve via a catheter inserted either through a vein or artery (femoral vein; femoral, subclavian, or axillary arteries; or the ascending aorta) or through the apex of the heart via an incision in the chest wall (transapical approach).  Edwards Lifesciences® began a clinical trial of its Edwards SAPIEN™ Transcatheter heart valve technology in patients with aortic stenosis who are considered high-risk for conventional open-heart valve surgery.

The Food and Drug Administration (FDA) approved the Medtronic Melody® Transcatheter Pulmonary Valve (TPV) and Ensemble® Transcatheter Valve Delivery System in 2010 under the Humanitarian Device Exemption (HDE) program “for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:

  • Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, and
  • Dysfunctional Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication for intervention, and either:
    • Regurgitation: ≥  moderate regurgitation, or
    • Stenosis: mean RVOT gradient > 35 mmHg”.

Rationale:

A peer-review literature search was performed through November 2010. 

In 2007, Edwards Lifesciences began a randomized, controlled clinical trial of its Edwards SAPIEN Transcatheter heart valve technology in patients with aortic stenosis who are considered high-risk for conventional open-heart valve surgery.  Subjects will be randomized to either the investigational device, or current surgical or medical management.   The anticipated completion date of the clinical trial is 2014 with an estimated enrollment of 1,040.  No PHV is approved by the FDA at this time.  Pending publication of this trial, available evidence is lacking to warrant coverage of this procedure and/or device.

2011 Update

A peer-review literature search was performed through April 2011.

In 2008, the National Institute for Health and Clinical Excellent (NICE) issued guidance on transcatheter aortic valve implantation for aortic stenosis (only).  The guidance stated: “The evidence on transcatheter aortic valve implantation for aortic stenosis is limited to small numbers of patients who were considered to be at high risk for conventional cardiac surgery.  It shows good short-term efficacy but there is little evidence on long-term outcomes.  There is a potential for serious complications; however, the patients on whom this procedure has been used have a poor prognosis without treatment and are at high risk if treated by open heart surgery.  Clinicians wishing to use this procedure should do so only with special arrangements for clinical governance, consent and for audit or research.”   No specialty association guidelines were found on pulmonary valve replacement devices.

Medtronic, Inc. received approval from the FDA for their Melody transcatheter pulmonary valve device through a humanitarian device exemption.  Medtronic began a non-randomized, open-label, single group assignment, interventional clinical trial (NCT007480870) in January 2007 with an estimated enrollment of 150 and an estimated completion date of August 2015.  Short-and medium-term outcomes of the trial were published to support an HDE regulatory filing with the FDA.

Pending publication of completed clinical trials regarding catheter-based implantation of heart valves, available evidence is lacking to warrant coverage of this procedure and/or device. Therefore, transcatheter heart valve replacement remains experiment, investigational and unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0256T, 0257T, 0258T, 0259T, 0262T

HCPCS Codes

 

ICD-9 Diagnosis Codes

395.0, 395.2, 396.0, 396.2, 396.3, 397.1, 424.3, 746.02, 746.3, 746.5

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

I06.0, I06.2, I08.0, I09.89, I37.0 - I37.9, Q22.1, Q23.0, Q23.2

ICD-10 Procedure Codes

None


Medicare Coverage:

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position.  Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written.  See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

The PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial. Available at <http://www.clinicaltrials.gov> (Accessed December 6, 2010).

Edwards SAPIEN Transcather Heart Valve. Available at <www.edwards.com> (accessed December 6, 2010).

Coeytaux, R., Williams, J. et al. Narrative Review: Percutaneous Heart Valve Replacement for Aortic Stenosis: State of the Evidence. Ann Intern Med (2010) 153(5):314-24.

FDA—HDE H08002 Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10) U.S. Food and Drug Administration – (2010 Jan 25).  Available at <http://www.fda.gov> (accessed – 2011 April 13).

Transcatheter aortic valve implantation for aortic stenosis. June 2008. National Institute for Health and Clinical Excellence. Available at < www.nice.org> (accessed – 2011 April 13).

Policy History:

6/15/2011        Document updated with literature review.  Coverage unchanged. The following was added: Medtronic Melody® Transcatheter Pulmonary Valve (TPV) and Ensemble® Transcatheter Valve Delivery System was added. The number of the policy was changed from SUR717.015 to SUR707.028.

3/1/2011          New Medical Document converted from position statement.  Percutaneous heart valve replacement is considered experimental, investigational and unproven by any method.

1/1/2011          Position Statement. Percutaneous heart valve replacement is considered experimental, investigational and unproven by any method.

Archived Document(s):

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