HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-230-014
Topic:
Sacroiliac Fusion Surgery and Axial-Lumbosacral Interbody Fusion
Section:
Surgery
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
April 2018
Annual Review:
April 2018
 
 

Axial Lumbosacral Interbody Fusion

Axial lumbosacral interbody fusion (Axial LIF, also called pre-sacral, trans-sacral, or paracoccygeal interbody fusion) is a minimally invasive technique that is performed under fluoroscopic guidance. This procedure is designed to provide anterior access to the L5-S1 disc spaces for interbody fusion.

Sacroiliac Joint Fusion

Sacroiliac joint (SIJ) fusion is a treatment for sacroiliac joint conditions such as joint damage resulting from trauma, infection, cancer, and joint instability (e.g. pelvic fracture). SIJ fusion may be performed as a minimally invasive procedure or as an open surgical procedure. Percutaneous sacroiliac joint fusion is a minimally invasive approach in which instrumentation involving cages or screws, with or without bone graft, are placed percutaneously in order to achieve a fusion. 

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Sacroiliac Joint Fusion - Open

SIJ fusion may be considered medically necessary when ALL of the following criteria are met:

  • Appropriate imaging studies demonstrate localized sacroiliac joint pathology; and
  • The individual is a nonsmoker, or in the absence of progressive neurological compromise will refrain from use of tobacco products for at least six (6) weeks prior to the planned surgery; and 
  • ANY of the following:
    • Post-traumatic injury of the SIJ (e.g., following pelvic ring fracture); or
    • As an adjunctive treatment for SIJ infection or sepsis; or
    • Management of sacral tumor (e.g., partial sacrectomy); or
    • When performed as part of multisegmental long fusions for the correction of spinal deformity (e.g., idiopathic scoliosis, neuromuscular scoliosis).

SIJ fusion is considered experimental/investigational and therefore non-covered for ALL of the following conditions because the safety and/or effectiveness of this procedure cannot be established by the available published peer-reviewed literature:

  • Mechanical low back pain; and
  • SIJ syndrome; and
  • Degenerative sacroiliac joint; and
  • Radicular pain syndromes.

SIJ fusion performed for any other indication not listed above will be considered not medically necessary.

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Sacroiliac Joint Fusion – Percutaneous or Minimally Invasive

Percutaneous or minimally invasive SIJ fusion using a FDA-approved implant may be considered medically necessary when ALL of the following criteria are met:

·         Failure to respond (i.e., continued pain that interferes with activities of daily living and/or results in functional disability) to a minimum of six (6) months of intensive nonoperative treatment that must include medication optimization, activity modification, bracing and active therapeutic exercise targeted at the lumbar spine, pelvis, SIJ and hip including a home exercise program; and

·         Reported pain is typically unilateral pain that is caudal to the lumbar spine (L5 vertebra), localized over the posterior SIJ, and consistent with SIJ pain; and

·         Thorough physical examination demonstrates localized tenderness with palpation over the sacral sulcus (Fortin’s point, ie, at the insertion of the long dorsal ligament inferior to the posterior superior iliac spine or PSIS) in the absence of tenderness of similar severity elsewhere (e.g., greater trochanter, lumbar spine, coccyx) and that other obvious sources for their pain do not exist; and

·         Positive response to a cluster of three (3) provocative tests (e.g., thigh thrust test, compression test, Gaenslen’s test, distraction test, Patrick’s sign, posterior provocation test);

o    Note: thrust test is not recommended in pregnant patients or those with connective tissue disorders; and

·         Absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); and

·         Diagnostic imaging studies that include ALL of the following:

o    Imaging (plain radiographs and a CT [computed tomography] or MRI [magnetic resonance imaging]) of the SIJ that excludes the presence of destructive lesions (e.g., tumor, infection) or inflammatory arthropathy that would not be properly addressed by percutaneous SIJ fusion; and

o    Imaging of the pelvis (AP [anteroposterior] plain radiograph) to rule out concomitant hip pathology; and

o    Imaging of the lumbar spine (CT or MRI) to rule out neural compression or other degenerative condition that can be causing low back or buttock pain; and

o    Imaging of the SIJ that indicates evidence of injury and/or degeneration; and

·         Diagnostic confirmation of the SIJ as the pain generator demonstrated by at least 75% reduction of pain for the expected duration of the anesthetic used following an image-guided, contrast-enhanced intra-articular SIJ injection on two (2) separate occasions; and

·         A trial of at least one (1) therapeutic intra-articular SIJ injection (i.e., corticosteroid injection).

Percutaneous or minimally invasive sacroiliac joint fusion for the following indications is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this procedure cannot be established by the available published peer-reviewed literature:

·         When ALL of the above criteria have not been met; or

·         Use of a non-FDA-approved minimally invasive or percutaneous SIJ fusion implant; or

·         Systemic arthropathy, (e.g., ankylosing spondylitis or rheumatoid arthritis); or

·         Acute, traumatic instability of the SIJ; or

·         Other pathology that would substantially prevent the patient from deriving benefit.

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Axial LIF is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this procedure cannot be established by 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.

Lumbar spine/sacroiliac fusion surgery and Axial LIF is 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


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



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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.

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.