HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 

Medical Policy:
S-245-005
Topic:
Percutaneous Left Atrial Appendage Closure Devices
Section:
Surgery
Effective Date:
October 1, 2019
Issued Date:
October 1, 2019
Last Revision Date:
October 2019
Annual Review:
March 2019
 
 

 

A left atrial appendage closure (LAA) device is an implant based alternative to anticoagulation. The closure device is used to reduce the risk of LAA blood clots from entering the bloodstream and causing a stroke in patients with nonvalvular atrial fibrillation (NVAF).

The WatchmanTM percutaneous LAA closure device is indicated to reduce the risk of thromboembolism from the LAA in patients with NVAF who are at increased risk for stroke and systemic embolism.

 

Policy Position

The Watchman LAA closure device may be considered medically necessary to reduce the risk of thromboembolism from the LAA in patients with NVAF, when BOTH of the following criteria are met:

  • There is an increased risk of stroke and systemic embolism based on CHADS2* greater than or equal to two (2) or CHA2DS2-VASc** score greater than or equal to three (3) and systemic anticoagulation therapy is recommended; and
  • The long-term risks of systemic anticoagulation outweigh the risks of the device implantation.

*CHADS2 score: Congestive heart failure, hypertension, age greater than 75, diabetes, stroke/transient ischemia attack/thromboembolism.

** CHA2DS2-VASc score: Congestive heart failure, hypertension, age greater than or equal to 65, diabetes, stroke/transient ischemia attack/thromboembolism, vascular disease, sex category.

NVAF is defined as a rhythm disturbance that occurs in the absence of rheumatic mitral stenosis, a mechanical or bioprosthetic heart valve or mitral valve repair. 

The Watchman device for any other indication is considered experimental/investigational, and therefore non-covered.  Safety and/or effectiveness for any other use cannot be established by review of the available published peer-reviewed literature.

The use of other percutaneous LAA closure devices, including but not limited to the Lariat, PLAATO, and Amplatzer devices, for stroke prevention in patients with atrial fibrillation is considered experimental/investigational, and therefore non-covered.  Safety and/or effectiveness of these devices cannot be established by review of the available published peer-reviewed literature.

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Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Percutaneous LAA closure devices are typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract, and subject to the applicable laws of your state.


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

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as: 
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as: 
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator. 

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. 

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: 

U.S. Department of Health and Human Services 
200 Independence Avenue, SW 
Room 509F, HHH Building 
Washington, D.C. 20201 
1-800-368-1019, 800-537-7697 (TDD) 

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.