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Section: Surgery
Number: S-152
Topic: Transcatheter Closure Devices for Congenital Heart Defects (Amplatzer, CardioSeal)
Effective Date: August 1, 2005
Issued Date: August 1, 2005
Date Last Reviewed: 06/2005

General Policy Guidelines

Indications and Limitations of Coverage

Procedure codes 93580 and 93581 include a right heart catheterization procedure (93501, 93529-93533) as well as the injection of contrast for atrial and ventricular angiograms (93539, 93543, 93555). These codes should not be reported separately in addition to code 93580, 93581, or 93799 (duct occluder).

Amplatzer

The Amplatzer Septal Occluder is a percutaneously implanted device. Closure of secundum atrial septal defects using this device may be considered medically necessary in patients with the following indications:

  • Those with echocardiographic evidence of ostium secundum atrial septal defect; and,
  • Clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or right ventricular enlargement).

The use of the Amplatzer device may also be considered medically necessary in patients who have undergone a fenestrated fontan procedure and now require closure of the fenestration.

If the implantation of the Amplatzer Septal Occluder device is reported for an indication other than those listed, it should be denied as not medically necessary and, therefore, not covered. A participating, preferred, or network provider cannot bill the member for the denied service.

The implantation of the Amplatzer device should be reported under procedure code 93580.

In addition, the Amplatzer Duct Occluder is a percutaneous transcatheter occlusion device.  Implantation of this device is considered medically necessary for the nonsurgical closure of patent ductus arteriosus (PDA)(747.0).

The implantation of the Amplatzer Duct Occluder device should be reported under procedure code 93799.

CardioSeal

The CardioSeal Septal Occluder is also a percutaneously implanted device which has been approved for ventricular septal defects (VSD). If the implantation of the CardioSeal device is reported for any other indication, it should be denied as not medically necessary and, therefore, not covered. A participating, preferred, or network provider cannot bill the member for the denied service.

The implantation of the CardioSeal device should be reported under procedure code 93581.

Description

The FDA has approved several transcatheter cardiac occlusion devices (Amplatzer Septal Occluder, Amplatzer Duct Occluder,  and CardioSeal Septal Occluder) for use in minimally invasive repair of certain congenital cardiac defects. These devices offer an alternative to conventional open heart surgery.


NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

935809358193799   

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Closure of patent foramen ovale (PFO) using a transcatheter approach with an FDA-approved device may be considered medically necessary in patients with a history of cryptogenic stroke and who have failed or are not candidates for a course of anticoagulant therapy.

Also refer to General Policy Guidelines

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

MPRM 2.02.09

From the Food and Drug Administration, Journal of American Medical Association, Vol. 287, No. 5, February 6, 2002

Right Ventricular Form and Function After Percutaneous Atrial Septal Defect Device Closure, Journal of the American College of Cardiology, Vol. 37, No. 8, 2001

Comparison of Results of Closure of Secundum Atrial Septal Defect by Surgery Versus Amplatzer Septal Occluder, The American Journal of Cardiology, Vol. 88, September 1, 2001

Percutaneous Closure with Amplatzer Device is a Safe and Efficient Alternative to Surgery in Adults with Large Atrial Septal Defects, American Heart Journal, Vol. 142, No. 3, April 2001

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Glossary





This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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