Transcatheter Closure of Patent Ductus Arteriosus

POLICY NUMBER

L.7.01.427

DESCRIPTION

The ductus arteriosus is the vascular remnant of the left sixth aortic arch, connecting the main pulmonary artery to the aorta. A patent ductus arteriosus (PDA) is the persistent opening of the channel beyond its expected time of closure during the first few days of life. Symptoms are related to the size of the ductus; a large non-restrictive ductus with a left to right shunt can cause cardiac failure, while small restrictive PDAs are associated with an increased risk of infective endarteritis. Because of the twin threats of heart failure or endarteritis, it is recommended that all PDAs that persist after the age of 2 years be surgically closed with ligation or division of the PDA.

Open surgical treatment of the PDA is a low-risk procedure if performed electively. However, over the past several decades there has been interest in developing a catheter-based technique to close PDAs, thus eliminating the need for general anesthesia, a thoracotomy, and an extended hospital stay and convalescence. A number of devices have been developed for this purpose.

The Gianturco coil, also referred to as the Cook embolization coil, is an arterial and venous occlusive device that was marketed prior to 1976, when the U.S. Food and Drug Administration (FDA) formally acquired regulatory authority over devices. (Please note that the Gianturco coil is entirely different than the Gianturco stent, which is used in coronary arteries.) Therefore, the Gianturco device has never undergone formal FDA approval but is available for clinical use. However, the Gianturco coil has been investigated for PDA closure. Transcatheter insertion of the coil is typically an outpatient procedure performed in the catheterization lab. General anesthesia may only be required in those very young patients who cannot reliably hold still during the procedure. General anesthesia in a child younger than 1-year-old may require overnight hospitalization.

In 2003, the Amplatzer Duct Occluder received FDA approval, with the specific indication for non-surgical closure of patent ductus arteriosus. This device is a self-expandable device made from a Nitinol wire mesh and polyester fabric. As the occluder is implanted, it expands outward, and the wires push against the wall of the ductus. The polyester fabric induces thrombosis, which closes the communication.

Note: The Amplatzer PFO Occluder device (FDA approved in 2016) and the Gore Cardioform Septal Occluder (FDA approved in 2018) for the closure of patent foramen ovale (PFO) for prevention of recurrent strokes in certain patients are outside of the scope of this policy.

POLICY

Transcatheter closure of a patent ductus arteriosus using an FDA-approved device may be considered medically necessary.

Transcatheter closure of a patent ductus arteriosus using other non–FDA-approved devices is considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

According to the labeled indications of the Amplatzer Duct Occluder, the following are contraindications for the use of this device:

• Patients weighing less than 6 kg

• Patients less than 6 months of age

• Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained

• Active endocarditis or other infections producing bacteremia

• Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size

• Patients with pulmonary hypertension with pulmonary vascular resistance of >8 Woods units or Rp/Rs of >0.4.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

05/09/2012: Separate policy created. Policy information was previously included in the Amplatzer® Devices policy.

12/13/2012: Policy reviewed; no changes.

09/01/2015: Code Reference section updated for ICD-10. Remove ICD-9 procedure codes 35.50 and 35.52; removed ICD-9 diagnosis code 745.5. Added ICD-9 procedure code 38.85.

06/08/2016: Policy number L.7.01.427 added. Policy Guidelines updated to add medically necessary and investigative definitions.

07/05/2023: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/25/2024: Policy reviewed; no changes.

04/15/2025: Policy description updated to note that the Amplatzer PFO Occluder device (FDA approved in 2016) and the Gore Cardioform Septal Occluder (FDA approved in 2018) for the closure of patent foramen ovale (PFO) for prevention of recurrent strokes in certain patients are outside of the scope of this policy.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.61

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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