Medical & Reimbursement Policies
Medical Policy
Policy Id
Topic
Section
Effective Date
Issued Date
Last Revision Date
Annual Review
Prepared By
DISCLAIMER
Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
POLICY STATEMENT
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
Purpose
This medical policy outlines Highmark Health Options services for Transcatheter Closure Devices for Septal Defects.
Definitions
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Transcatheter Percutaneous Cardiac Occlusion Devices – Are for use in minimally invasive repair of cardiac septal defects. These defects can be congenital or acquired. These devices offer an alternative to conventional open-heart surgery.
Policy Position
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup
Procedures
A U.S. Food and Drug Administration (FDA) approved percutaneous septal occlusion device used according to labeling, may be considered medically necessary for ANY following cardiac septal defects:
- Closure of a secundum atrial septal defect (ASD); or
- Closure of a fenestrated septal opening as a result of the Fontan procedure; or
- Closure of a patent ductus arteriosus (PDA); or
- Closure of a complex ventricular septal defect (VSD); or
- For individuals that are considered high risk for standard transarterial or transarterial surgical VSD closure due to anatomic conditions and overall medical condition; or
- Closure of surgical shunts or collaterals.
A percutaneous septal occlusion device is contraindicated for use in individuals with ANY of the following:
- Known to have local or generalized sepsis, or any systemic infection that cannot be successfully treated within one (1) month prior to device placement; or
- Whose size or condition would cause the individual to be a poor candidate for cardiac catheterization; or
- With the margins of the defect less than five (5) mm to the coronary sinus, AV valves and right upper lobe pulmonary vein; or
- With thrombus at or near the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained unless the individual is protected with other embolic protection devices such as a vena cava filter; or
- Whose anatomy would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins should a septal occlude be used; or
- With an intra-cardiac mass or vegetation; or
- Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin, successfully prior to device placement; or
- Whose vasculature is inadequate to accommodate a septal occlusion device.
All other devices or uses are considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-review literature.
Transcatheter closure of patent foramen ovale (PFO) with an FDA approved device may be considered medically necessary in individuals 18 years of age or older, with a history of ischemic stroke presumed to be secondary to a paradoxical embolism, following a negative workup for other causes of ischemic stroke.
All other devices or uses are considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Post-Payment Audit Statement
The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.
Place of Service: Inpatient
Experimental/investigational (E/I) services are not covered regardless of place of service.
REIMBURSEMENT
Participating facilities will be reimbursed per their Highmark Health Options contract.
References
InterQual® Level of Care Criteria 2019, Acute Care Adult, McKesson Health Solutions, LLC.
Shah R, Nayyar M, Jovin IS, et al. Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke: A systematic review and meta-analysis. Ann Intern Med. 2018;168(5):335-342.
De Rosa S, Sievert H, Sabatino J, et al. Percutaneous closure versus medical treatment in stroke patients with patent foramen ovale: A systematic review and meta-analysis. Ann Intern Med. 2018;168(5):343-350.
U.S. Food and Drug Administration. Summary of safety and effectiveness data. Gore Cardioform Septal Occluder.March 30, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050006s060b.pdf. Accessed June 03, 2021.
Food and Drug Administration (FDA). Summary of safety and effectiveness data (SSED): Patent Foramen Ovale (PFO) occluder (PMA P120021) 2016;https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120021B.pdf. Accessed June 03, 2021.
Lee PH, Song JK, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: The defense-PFO trial. J Am Coll Cardiol. 2018;71(20):2335-2342.
Alushi B, Lauten A, Cassese S, et al. Patent foramen ovale closure versus medical therapy for prevention of recurrent cryptogenic embolism: Updated meta-analysis of randomized clinical trials. Clin Res Cardiol. 2018;107(9):788-798.
Wintzer-Wehekind J, Alperi A, Houde C, et al. Long-term follow-up after closure of patent foramen ovale in patients with cryptogenic embolism. J Am Coll Cardiol. 2019;73(3):278-287.
Tobis JM, Charles A, Silberstein SD, et al. Percutaneous closure of patent foramen ovale in patients with migraine: The premium trial. J Am Coll Cardiol. 2017;70(22):2766-2774
Jalal Z, Hascoet S, Gronier C, et al. Long-term outcomes after percutaneous closure of ostium secundum atrial septal defect in the young: A nationwide cohort study. JACC Cardiovasc Interv. 2018;11(8):795-804.
Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease: A report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. J Am Coll Cardiol. 2019;73(12):e81-e192.
Kashyap T, Sanusi M, Momin ES, et al. Transcatheter occluder devices for the closure of atrial septal defect in children: How safe and effective are they? A systematic review. Cureus. 2022;14(5):e25402.
Musto C, Cifarelli A, Dipasquale F, et al. A comparison between gore cardioform and amplatzer septal occluder for percutaneous closure of patent foramen ovale associated with atrial septal aneurysm: Clinical and echocardiographic outcomes. J Invasive Cardiol. 2021;33(11):E857-E862.
Kumar V, Ward C, Justo R, et al. The gore septal occluder (GSO) for multiple indications in children - An intention to treat analysis. Heart Lung Circ. 2021;30(10):1578-1581.
Santoro G, Castaldi B, Cuman M, et al. Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience. Int J Cardiol. 2021;327:68-73.
