HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
S-235-006
Topic:
Spine – Graft/Implant
Section:
Surgery
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
October 2018
Annual Review:
April 2018
 
 

Recombinant human bone morphogenetic protein (rhBMP) serves as a replacement for or adjunct to autologous bone grafts (autografts). It is used in spinal fusion surgery for degenerative disc disease to promote the bone growth that results in fusion.

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

Recombinant human bone morphogenetic protein rhBMP-2 (InFuse ®) may be considered medically necessary for the following indications:

·         Approved lumbar spine fusion; and

·         High risk of fusion failure*;  and

·         When autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion; and

·         In combination with FDA-approved fusion device for a single-level anterior interbody lumbar or lumbo-sacral fusion (e.g., ALIF) surgery for:

o    Degenerative disc disease at one level from L2-S1; and

o    No more than Grade III spondylolisthesis at the involved level

 

*High risk for fusion failure can be defined by the presence of one or more of the following:

·         One or more previous failed spinal fusion(s)

·         Grade III or worse spondylolisthesis

·         Fusion to be performed at more than one level

·         Current tobacco use

·         Diabetes

·         Renal disease

·         Alcoholism

·         Osteoporosis

·         Steroid use

 

rhBMP-2 (InFuse®) is considered experimental/investigational and therefore non covered for ANY of the following indications due to lack of supporting evidence in published peer-reviewed literature:

·         Skeletally immature patient; or

·         Planned use of grafting in the vicinity of a resected or extant tumor; or

·         Known contraindications (e.g., pregnancy, hypersensitivity/allergy, infection); or

·         Treatment of the cervical or thoracic spine; or

·         Lumbar spine surgery via posterior approach

 

The following bone graft substitutes for the enhancement of bone healing are considered experimental/investigational and therefore non-covered due to lack of supporting evidence in published peer-reviewed literature:

·         rhBMP-7 (i.e.,OP–1™)

·         INFUSE/MASTERGRAFT™ Posterolateral Revision Device

·         Human amniotic membrane bone graft substitute

·         Cell-based substitutes (e.g., mesenchymal stem cell therapy) when used to enhance bone healing

·         Human growth factors (e.g., fibroblast growth factor, insulin like growth factor) when used to enhance bone healing

·         Platelet rich plasma (e.g., autologous platelet derived growth factor) when used to enhance bone healing

·         Allograft bone graft substitutes used exclusively as stand-alone stabilization devices for fusion (e.g.,TruFuse® for isolated facet fusion, NuFix™ for isolated facet fusion, BacFast® HD for isolated facet fusion)

·         Bone graft substitutes used to reduce donor site morbidity (e.g., iliac crest donor site reconstruction)

·         Ceramic-based products (e.g., b-TCP)

·         OptiMesh® deployable grafting system

20930

20931

20936

20937

20938

 

 


Related Policies

Refer to:  Medical Policy S-230 f Lumbar/Spine Fusion Surgery and Axial Lumbosacral Interbody Fusion. 

Procedure Code 20930 is not a stand-alone procedure and must be used separately with a primary spinal procedure code.



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.