Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Transcatheter Closure of Cardiac Septal Defects

Policy #:11.02.11g

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Transcatheter closure of cardiac septal defects using a US Food and Drug Administration (FDA)--approved closure device according to the labeled indications is considered medically necessary and, therefore, covered for the following:
  • Closure of ostium secundum atrial septal defects (ASDs) in individuals with clinical evidence of right ventricular volume overload, as indicated for ASD closure have echocardiographic evidence of 1.5:1 degree of left-to-right shunt or right ventricular enlargement
  • Closure of the fenestration in individuals who have undergone a fenestrated Fontan procedure
  • Treatment of complex ventricular septal defects (VSDs) of significant size to warrant closure in individuals who are at high risk for standard transatrial or transarterial surgical closure due to anatomic conditions or overall medical condition (e.g., the need for a left ventriculotomy, a failed previous VSD closure, multiple apical and/or anterior muscular VSDs [Swiss cheese septum], posterior apical VSDs covered by trabeculae)
  • Closure of patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in adults, 60 years of age or less, who have had a cryptogenic stroke due to a presumed paradoxical embolism, and have had a clinical assessment by both a neurologist and cardiologist to exclude known causes of ischemic stroke

EXPERIMENTAL/INVESTIGATIONAL

All other uses of transcatheter closure devices are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these devices for other purposes have not been established by review of the available published literature.

The use of any transcatheter closure device for cardiac septal defects, including the use in the closure of patent foramen ovale (PFO), that has not been approved by the FDA is considered experimental/investigational and, therefore, not covered.

Transmyocardial transcatheter closure with implant, with or without cardiopulmonary bypass, is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to, records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, transcatheter closure of cardiac septal defects is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational OR not medically necessary are not eligible for coverage or reimbursement by the Company. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA issued a premarket approval (PMA) for the AMPLATZER® Septal Occluder on December 5, 2001 and the AMPLATZER® Muscular VSD Occluder on September 07, 2007. The FDA issued a PMA for the Gore Helex® Septal Occluder on August 11, 2006. The FDA issued a PMA for the AMPLATZER® PFO Occluder on October 28, 2016. The FDA issued a supplemental PMA for Gore Cardioform Septal Occluder on March 30, 2018.

Description

Cardiac septal defects are openings in the walls (septa) that separate the chambers of the heart. Defects between the upper chambers (atria) are referred to as atrial septal defects, whereas defects in the lower chambers (ventricles) are referred to as ventricular septal defects. The size and clinical course of the defect can be variable, with many either partially or completely closing in the first few years of life. Transcatheter occlusion devices are intended as alternatives to surgical repair. Device design varies, but all are inserted percutaneously and advanced by vascular access to the defect site, where the device is deployed. Transcatheter patent foramen ovale (PFO) occluders consist of a single or paired wire mesh discs that are covered or filled with polyester or polymer fabric that are placed over the septal defect. Over time, the occlusion system is epithelialized.

ATRIAL SEPTAL DEFECTS

Atrial septal defects (ASDs) represent an abnormality in the development of the heart that results in free communication between the atria. Atrial septal defects can occur in any portion of the atrial septum, including the ostium primum, ostium secundum, and sinus venosus. Ostium secundum ASDs account for 75 to 80 percent of all ASDs, and are located in the area of the fossa ovalis, the site corresponding to the fetal foramen ovale. For individuals with ASDs that require closure, nonrandomized comparative studies and single-arm case series show high success rates of closure using closure devices approaching the high success rates of surgery. Transcatheter closure of cardiac septal defects using catheter closure devices has evolved as an alternative to open surgical intervention in select individuals with secundum septal defects.

US FOOD AND DRUG ADMINISTRATION (FDA)
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to the Amplatzer® Septal Occluder for the treatment of ostium secundum ASDs in individuals who have evidence of right ventricular volume overload (i.e., 1.5 to 1 degree of left to right shunt or right ventricle enlargement). The FDA has granted PMA to the Gore Helex® Septal Occluder for the treatment of ostium secundum ASDs.

PATENT FORAMEN OVALE (PFO)

The foramen ovale is an opening between the right and left atria that is a component of fetal circulation. This opening normally closes soon after birth, but a PFO occurs when the flap-like opening does not close. Patent foramen ovale differs from ASDs in morphology and associated symptoms. Patent foramen ovales are thought to be associated with paradoxical embolism (i.e., passage of a clot from a vein to an artery). Furthermore, the flap-like opening associated with PFO is usually not clinically significant in healthy adults, but with conditions such as pulmonary hypertension, chronic obstructive pulmonary disease, or pulmonary embolism may cause the right atrial pressure to be elevated, causing an increased potential right to left shunting through the PFO.

PFO CLOSURE FOR CRYPTOGENIC STROKE
Although a direct causal relationship has not been established for PFO and the implication in the mechanism of cryptogenic stroke, PFO is presumably responsible for paradoxical embolism resulting in cerebrovascular accidents or transient ischemic attacks(TIA). Transcatheter closure has been proposed as an alternative to medical therapy (e.g., antiplatelet therapy) in individuals with PFO associated with cryptogenic stroke.

The relevant review of evidence for PFO closure for cryptogenic stroke includes three clinical trials. The CLOSURE I study was a multicenter, randomized, open-label trial of percutaneous closure with a STARFlex device (NMT Medical, Boston, MA) compared with medical therapy alone in adult patients with PFO and a cryptogenic stroke/TIA. Percutaneous closure was randomly assigned to 447 participants, and 462 were assigned to medical therapy. Those assigned to the closure arm had the procedure performed soon after randomization, usually within one week. After the procedure, all participants were given a standard antiplatelet regimen, including clopidogrel, 75 mg daily for 6 months, and aspirin, 81 or 325 mg daily for 2 years. Patients assigned to medical therapy were either treated with warfarin, aspirin (325 mg daily), or both, at the investigator's discretion. The primary end point was a composite of stroke and TIA at 2 years, death from any cause during the first 30 days after treatment, and death from neurologic causes at 2 years. Significant composite primary outcome were not reached amongst the two treatment groups (adjusted hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.45 to 1.35; p=0.37). An increase of adverse events were reported for the closure arm, specially vascular procedural complications and atrial fibrillation. The trial utilized a device whose safety and effectiveness has not been established due to a lack of clinical evidence and controlled clinical studies and is no longer commercially available.

Percutaneous closure of PFO in cryptogenic embolism, the PC trial (Meier 2013), was a multicenter randomized controlled trial comparing PFO closure with medical therapy in 414 individuals with a prior cryptogenic stroke or a peripheral thromboembolic event and documented PFO. Individuals were randomly assigned to PFO closure with the Amplatzer® PFO Occluder device or to receive medical therapy. The primary end point was a composite of death, nonfatal stroke, transient ischemic attack (TIA), or peripheral embolism. Patients were followed for four years following randomization. Analysis was performed on data for the intention-to-treat population. The authors concluded that closure of a PFO for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy.

The Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial was a prospective, multicenter, randomized (1:1), event-driven, open label, clinical trial, which enrolled 980 individuals evaluating whether PFO closure with the AMPLATZER® PFO Occluder (St. Jude, Plymouth, MN) was superior to the current standard medical treatment in the prevention of recurrent stroke. Primary efficacy endpoints included a composite of event occurrences: recurrence of a nonfatal ischemic stroke or fatal ischemic stroke or early post-randomization death. Secondary efficacy endpoints included complete closure of the defect demonstrated by transesophageal echocardiography and bubble study at the six month follow-up for device group; absence of recurrent symptomatic cryptogenic nonfatal stroke or cardiovascular death; and absence of transient ischemic attack.

In the primary intention-to-treat (ITT) analysis, there was no reported significant benefit (i.e., 51 percent reduced risk of recurrent stroke) associated with closure of a PFO in adults who had a cryptogenic ischemic stroke. Further studies of PFO closure in this population was warranted to determine longer-term information regarding benefits, risks, and differential treatment effects in sub-populations. The trial was an event driven study designed to distinguish superiority between the device and medical treatment with two primary endpoints. Enrollment would stopped and device superiority would be declared if within the first 12 events, the number of primary endpoint events for the medical treatment group equals or exceeds 10. Additionally, enrollment would be stopped once 25 events were observed. Device superiority would be declared if within the first 25 events, the number of primary endpoint events for the medical treatment group equals or exceeds 19. The ITT analysis reported 16 event occurrences in the medical treatment arm, thus the trial was unable to report superiority.

In a 2015 supplementary statistical analysis of the RESPECT trial, (5.5 years for the PFO occlusion arm and 4.9 years for the medical management arm), the ITT population showed no statistically significant difference in the incidence of all-cause strokes, which included both cryptogenic and “other” strokes (p=0.16). The authors acknowledge that nearly one third of strokes thought to be cryptogenic likely had another underlying mechanism. When subsequent strokes were restricted to cryptogenic stroke, there was a 54 percent relative risk reduction in recurrent cryptogenic stroke for the PFO closure group (p=0.042) versus those assigned to medical management (anticoagulants). An additional sensitivity analysis of all-cause stroke in individuals under the age of 60 (where a greater proportion of strokes are likely to be cryptogenic) reported a 52 percent relative risk reduction (p=0.035), demonstrating a statistical significant risk reduction. The results reported additional benefit within a subgroup in two-thirds of RESPECT trial individuals who had PFO characteristics of substantial shunt or atrial septal aneurysm with a 75 percent reduction in cryptogenic stroke risk (p=0.007).

In 2016, the Circulatory System Devices Panel of the Medical Devices Advisory Committee to the FDA met to make recommendations and vote on information related to the premarket approval application regarding the AMPLATZER® PFO Occluder System. The Panel acknowledged that the study found a 50 percent reduction in the rate of recurrent strokes in individuals treated with the PFO Occluder compared to medical management, although statistical significance for the primary endpoint was not met. The FDA granted premarket approval on October 28, 2016, for the AMPLATZER® PFO Occluder, (St. Jude, Plymouth, MN) indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in individuals, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. Although, the Panel also acknowledged loss of follow up as a result of subject withdrawals or treatment cross-over to receive off-label closure. There was an numerically lower stroke rate observed in the PFO Occluder group was presumably due to the prevention of paradoxical embolism. The Panel acknowledged the rate of serious adverse events was low in the RESPECT trial; however, noted that higher rates of deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed in the PFO Occluder group. The Panel agreed that modifications to the labeling for AMPLATZER® PFO Occluder System are needed including a statement regarding the need for adjunctive anti-thrombotic therapy in individuals treated with the device. In addition, the Panel recommended that the eligible population selection be carefully considered and defined within the labeling.

A review of long term (median follow-up 5.9 years) outcomes was performed for an extended follow-up analysis in the intention-to-treat population of the RESPECT trial. Saver et al reported a reduction in the hazard ratio amongst the two study arms. Utilizing comparable event driven analysis as the original trial, the authors reported recurrent ischemic stroke occurred in 18 of participants in the PFO arm whereas recurrent stroke was observed in 28 participants in the medical management arm. These results produced 0.58 events per 100 treatment years in the PFO group compared to 1.07 events per 100 treatment years (hazard ratio 0.55;95% confidence interval [CI], 0.31 to 0.99; P=0.046). Pertinent to the labeling of the device, the reviewer reported recurrent ischemic stroke of undetermined mechanism occurred in 10 of the participants in the PFO closure, whereas occurred in 23 participants in the medical management group, resulting in rate of 0.32 events per 100 treatment years and 0.86 events per 100 treatment years and a statistically significant hazard ratio between the treatment groups (hazard ratio, 0.38;95% CI, 0.18- 0.79; P=0.007). Previously addressed and documented elsewhere, the long term follow up results of the RESPECT trial, observed a disproportionate dropout rate between the two groups. Based on these results, they concluded PFO closure with the Amplatzer® PFO Occluder was associated with lower rates of recurrent ischemic strokes than medical treatment. The study acknowledge the rate of adverse outcomes, including the rate of venous thromboembolism was higher for the PFO closure group, but suggested that this could be mitigated with anticoagulant agents in specific populations for individuals with deep-vein thrombosis.

The FDA Office of Surveillance and Biometrics will continue to evaluate a single-arm, multi-centered post-approval study enrolling 860 participants to evaluate long-term safety and effectiveness of the AMPLATZER® PFO Occluder and the effectiveness of the training program for new operators. The primary endpoint of a rate recurrent ischemic stroke through 5 years, will be compared to a performance goal of 3.9%. The primary safety endpoint, which is the cumulative incidence of device- or procedure-related serious adverse events through 30 days includes the following events: atrial fibrillation, pulmonary embolism, deep vein thrombosis, device thrombus, device erosion, device embolization, ischemic stroke (if subject was not successfully implanted with a device), hemorrhagic stroke, major bleeding requiring transfusion or surgical or endovascular intervention, vascular access site complication requiring surgical intervention, and device- or procedure-related serious adverse event leading to death.

In 2018, FDA issued a supplemental PMA for the Gore Cardioform Septal Occluder. The Gore Cardioform Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: ostium secundum atrial septal defects (ASDs), patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in individuals, between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. The controlled, open-label REDUCE study assessed the efficacy and safety of PFO closure using Gore Septal Occluder Devices in 664 randomized subjects, ages 18 to 59 with a history of cryptogenic stroke, across 63 investigational sites in seven countries. The trial met its primary endpoint by showing a statistically significant, 76.6 percent (p = 0.001), reduction in recurrent ischemic stroke in individuals that underwent PFO closure in conjunction with antiplatelet therapy versus those who underwent antiplatelet therapy alone after an average of 3.4 years follow-up.

PFO CLOSURE FOR OTHER INDICATIONS
Studies show an association of PFO and the pathophysiologic mechanism of migraine headaches. The evidence for PFO closure with a catheter-based closure device in individuals with PFO and migraines includes randomized controlled trials of PFO closure, along with multiple observational studies reporting on the association between PFO and migraine. Relevant outcomes include quality of life, medication use, treatment-related morbidity and mortality, and symptoms. The available sham-controlled, randomized controlled trial (RCT) did not demonstrate significant improvements in migraine symptoms after PFO closure. In the prospective, randomized controlled, double-blind PREMIUM study, implantation of AMPLATZER PFO Occluder to close the PFO along with medical management did not meet the primary endpoint of 50 percent reduction in migraine attacks per month in 117 individuals compared to 103 who received a sham procedure and medical management. However, in a subgroup analysis the authors suggest that individuals with aura occurring during the majority of their attacks may respond more favorably to PFO closure, and that a small but significant percentage of migraine with aura individuals may experience complete remission of migraine. In individuals whose migraines mostly included aura, the rate of treatment response was greater with PFO closure than with the sham procedure (49 percent versus 23 percent; P = .015). In this subset, complete remission of migraine was reported in 10.8 percent of the closure group compared with 1.5 percent of the sham group (P = .02). In addition, nonrandomized studies show highly variable rates of migraine improvement after PFO closure. The American Headache Society (2016) states that conflicting results have emerged regarding the potential link between PFO and migraine, and the evidence that PFO closure improves migraine is weak. The evidence is insufficient to determine the effects of the technology on health outcomes.

There are currently no published FDA-approved clinical trials enrolling for transcatheter closure of PFO for migraine.

Several other medical conditions have been reported to occur more frequently in individuals with PFOs, including myocardial infarction with normal coronary arteries, decompression illness in response to change in environmental pressure, high altitude pulmonary edema, and obstructive sleep apnea. The body of evidence consists of only small case series and case reports. Comparative studies are needed to evaluate outcomes in similar groups who are treated with and without PFO closure. The evidence is insufficient to determine the effects of the technology on health outcomes.

US FOOD AND DRUG ADMINISTRATION (FDA)
The FDA has granted PMA to the Amplatzer® PFO Occluder (St. Jude Medical, Plymouth, MN)
for adult individuals, ages 60 years of age or less, who undergo a percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

FENESTRATED FONTAN

A Fontan procedure is performed to divert venous blood flow into the pulmonary artery without passage through the right ventricle; it is employed to correct complex anomalies in which there is only one functional ventricle. The initial Fontan procedure involved an anastomosis of the right atrial appendage to the pulmonary artery. Several modifications have been devised, including direct connection of the superior vena cava to the superior aspect of the pulmonary artery and tunneling of the inferior vena cava to the undersurface of the right pulmonary artery or into the main pulmonary artery. Construction of the conduit from the inferior vena cava has been performed both inside and outside the right atrium. A small hole may be intentionally left in the connection, hence, a "fenestrated Fontan." Individuals who undergo a fenestrated Fontan procedure often require closure of the fenestration during a follow-up surgical procedure.

US FOOD AND DRUG ADMINISTRATION (FDA)
The FDA has granted PMA to the Amplatzer® Septal Occluder for individuals who have undergone a fenestrated Fontan procedure and require closure of the fenestration.

VENTRICULAR SEPTAL DEFECTS

A ventricular septal defect (VSD) is an opening in the septum between the right and left ventricles. Management through conventional surgery for VSD is a widely accepted procedure with minimal operative mortality; however, it has a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. Transcatheter device closure technique provides an alternative to surgical closure, particularly for individuals who are considered high risk for the standard surgical closure.

US FOOD AND DRUG ADMINISTRATION (FDA)
On September 7, 2007, the FDA granted PMA to the AMPLATZER® Muscular VSD Occluder for the treatment of complex VSDs of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on the individual's overall medical condition. Muscular VSD closure with the AMPLATZER Muscular VSD Occluder was evaluated in a prospective, multi-center, nonrandomized, controlled investigation with a subset of 41 high-risk individuals. The primary purpose of the study was to determine if AMPLATZER Muscular VSD Occluder is safe and effective for the treatment of congenital muscular ventricular septal defects in individuals with a complex ventricular septal defect of significant size to warrant closure. The FDA reports that the data provided from the clinical outcomes is supportive of device safety and effectiveness of the Amplatzer Muscular VSD Occlude in high-risk individuals with muscular VSD. It should be noted that individuals amendable to surgical closure were excluded from the overall analysis because the amount and quality of data collected were insufficient to support safety and effectiveness on this lower risk population.

TRANSMYOCARDIAL TRANSCATHETER CLOSURE

Transmyocardial transcatheter closure with implant, with or without cardiopulmonary bypass, is a method of transcatheter closure that utilizes a sternotomy or a subxyphoid approach rather than percutaneous insertion with advancement by vascular access. In transmyocardial transcatheter closure, the closure device is guided across the septal defect and positioned accordingly.

US FOOD AND DRUG ADMINISTRATION (FDA)
At this time, no transcatheter closure device has been approved by the FDA for this type of approach. In addition, the safety and effectiveness of this procedure have not been established by review of the available published literature and clinical trials.
References


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Munkres AG, Ball TN, Chamogeorgakis T, Et al. Usefulness of percutaneous closure of patent foramen ovale for hypoxia. Proc (Bayl Univ Med Cent). 2015; 28(2): 204–206.

National Institutes of Health. Clinical trials: The Paradigm II trial: PFX Closure System in subjects with cryptogenic stroke, transient ischemic attack, migraine or decompression illness (NCT00196040). [FDA Web site]. 12/24/07. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00196040?term=foramen+ovale+devices&rank=8. Accessed March 28, 2018.

National Institutes of Health. Clinical trials: Premium migraine trial. (NCT00355056). [FDA Web site]. 07/19/2016. Updated 02/12/2016. Available at:https://clinicaltrials.gov/ct2/show/record/NCT00355056. Accessed March 28, 2018.

National Institutes of Health. Clinical trials: randomized evaluation of recurrent stroke comparing PFO closure to established current standard of care treatment.(NCT00465270). [FDA Web site]. 04/23/2007. Updated 07/21/2016. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT00465270?view=results. Accessed March 28, 2018.

National Institute for Health and Clinical Excellence (NICE). Endovasular closure of perimembranous ventricular septal defect. Interventional Procedure Guidance 172. [NICE Web site]. March 2010. Available at: https://www.nice.org.uk/guidance/ipg336/documents/endovascular-closure-of-perimembranous-ventricular-septal-defect-interventional-procedure-consultation. Accessed March 28, 2018.

National Stroke Association. A hole in the heart: The link between PFO and stroke. [National Stroke Association Web site]. 2007. Available at: http://www.stroke.org/site/DocServer/Patent_Foramen_Ovale_Fact_Sheet.pdf?docID=3681. Accessed March 28, 2018.

Nguyen BH, Satterfield L, Kim MS, et al.Percutaneous Closure of Patent Foramen Ovale for Systemic Hypoxemia: Patient Characteristics and Results in 104 Patients. [American Heart Association Web site]. 11/23/2010. Available at:
http://circ.ahajournals.org/content/122/Suppl_21/A21075.short?related-urls=yes&legid=circulationaha;122/Suppl_21/A21075. Accessed March 28, 2018.

Novitas Solutions, Inc.. Clinical Trials and Devices. 05/24/2016. Available at: http://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?_afrLoop=1686030010670168&_adf.ctrl-state=whs0v2dpu_177&contentId=00080341#!. Accessed March 28, 2018.

O'Gara PT, Messe SR, Tuzcu EM, et al. Percutaneous device closure of patent foramen ovale for secondary stroke prevention: a call for completion of randomized clinical trials: a science advisory from the American Heart Association/American Stroke Association and the American College of Cardiology Foundation. Circulation. 2009;119(20):2743-7.

Oho S, Ishizawa A, Akagi T, et al. Transcatheter closure of atrial septal defects with the Amplatzer septal occluder - a Japanese clinical trial. Circ J. 2002;66(9):791-794.

Onorato E, Melzi G, Casilli F, et al. Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients. J Interv Cardiol. 2003;16(1):43-50.

Patti G, Pelliccia F, Gaudio C, et al. Meta-analysis of net long-term benefit of different therapeutic strategies in patients with cryptogenic stroke and patent foramen ovale. Am J Cardiol. 2015;115(6):837-843.

Pickett CA, Villines TC, Ferguson MA, et al. Percutaneous closure versus medical therapy alone for cryptogenic stroke patients with a patent foramen ovale: meta-analysis of randomized controlled trials. Tex Heart Inst J. 2014;41(4):357-367.

Rengifo-Moreno P, Palacios IF, Junpaparp P, et al. Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials. Eur Heart J. 2013;34(43):3342-3352.

Rickers C, Hamm C, Stern H, et al. Percutaneous closure of secundum atrial septal defect with a new self-centering device ("angel wings"). Heart. 1998;80(5):517-521.

Sacco RL, Adams R, Albers G, et al. American Heart Association/American Stroke Association Council on Stroke. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals. Stroke. 2006;37:577-617.

Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med.2017. 377(11):1022-32.

Sievert H, Babic UU, Hausdorf G, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS (a multi-institutional European trial). Am J Cardiol. 1998;82(11):1405-1413.

Søndergaard L, Kasner SE, Rhodes JF, et al. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med.
2017;377(11):1033-1042.

Smitherman TA. Pharmacotherapy and other medical treatments. In: Clinician's Manual on Migraine. Switzerland: Springer International Publishing; 2016: 65.

Steinberg DH, Bertog SC, Momberger J, et al. Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® PFO in patients with stroke or transient ischemic attack. Catheter Cardiovasc Interv. 2015;85(7):1262-1267.

Stortecky S, da Costa BR, Mattle HP, et al. Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis. Eur Heart J. 2015;36(2):120-128.

Tucker ME. Another PFO closure study yields mixed migraine results. [Medscape Web site]. 06/26/2015. Available at: http://www.medscape.com/viewarticle/847080. Accessed September 18, 2017.

Udell JA, Opotowsky AR, Khairy P, et al. Patent foramen ovale closure vs medical therapy for stroke prevention: meta-analysis of randomized trials and review of heterogeneity in meta-analyses. Can J Cardiol. 2014;30(10):1216-1224.

US Food and Drug Administration (FDA). Information for Physicians and Patients on the Withdrawal of Two Humanitarian Device Exemptions (HDEs) For Patent Foramen Ovale (PFO) Occluders. Humanitarian Device Exemption. [FDA Web site]. 11/13/2017. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/ucm135747.htm. Accessed March 28, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Amplatzer® Muscular VSD Occluder. 510(k) summary. [FDA Web site]. 09/07/2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040040a.pdf. Accessed March 28, 2018.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

93580, 93581


EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT TRANSMYOCARDIAL TRANSCATHETER CLOSURE: 33999


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Q21.0 Ventricular septal defect
Q21.1 Atrial septal defect
Q21.2 Atrioventricular septal defect
Q21.3 Tetralogy of Fallot
Q21.9 Congenital malformation of cardiac septum, unspecified



HCPCS Level II Code Number(s)

C1817 Septal defect implant system, intracardiac




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.02.11g:
05/09/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on transcatheter closure of cardiac septal defects.
11/17/2017This policy has undergone a routine review, and the coverage position for closure of Patent Foramen Ovale has been revised from experimental/investigational to medical necessary with the following associated criteria to reduce the risk of recurrent ischemic stroke in adults, 60 years of age or less, who have had a cryptogenic stroke due to a presumed paradoxical embolism. Individuals indicated for PFO closure have transesophageal echocardiography, and a clinical assessment by both a neurologist and cardiologist to exclude known causes of ischemic stroke. There are no new codes added to this policy.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 11/17/2017
Version Issued Date: 11/17/2017
Version Reissued Date: 05/09/2018

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