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Coverage criteria policies

Mesenchymal stem cell therapy for orthopedic indications

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is not applicable for mesenchymal stem cell therapy for orthopedic procedures because it is considered investigational/experimental. The provider and facility will be liable for payment unless:

  • The provider notifies the member that a specific service has been determined by HealthPartners to be investigational/experimental; and
  • The member signs a waiver agreeing to pay for the specific non-covered service being rendered; and
  • The claim has been billed with a GA modifier indicating such. If the member has signed a waiver agreeing to pay for the specific service then the member will be liable for payment.

Coverage

Mesenchymal stem cell therapy for orthopedic procedures is not covered because long term safety and effectiveness has not been proven.

Indications that are not covered

Mesenchymal stem cell therapy for use in orthopedic procedures is not covered.

Applications not covered include but are not limited to:

  1. bone fractures and nonunions,
  2. repair or regeneration of musculoskeletal tissue,
  3. osteoarthritis,
  4. as an adjunct to spinal fusion,
  5. other orthopedic diseases of the spine

Sources of stem cells include human umbilical cord blood (CBMSCs) or birth associated tissues, adipose sourced from subcutaneous fat and bone marrow.

Stem cells that are isolated the same day and stem cells that have been “expanded” by culturing for use in orthopedic procedures are not covered.

Demineralized bone matrix (DBM) with mesenchymal stem cells is not covered.

Example products include but are not be limited to: Osteocel™, Osteocel Plus™, Ovation™, Regenexx®, Trinity Evolution®, Allostem®

Definitions

Allograft is a graft or transplant of tissue from an allogeneic donor. The donor and recipient are of different genetic origins.

Allogeneic cell therapy involves harvesting of cells from a healthy donor and not from the patient who is being treated.

Autologous means cells or tissue derived from a given individual intended for use in that individual.

Autologus bone marrow grafting (ABGM) means bone marrow that is aspirated from the patient. For the purposes of this policy, the bone marrow is applied to the necrotic (dead) bone via surgical techniques/injections to facilitate growth of healthy bone and healing of osteonecrosis or bone non-union.

Cellular therapy includes the administration of products with the intent of providing effector cells in the treatment of disease or support of other therapy.

Demineralized bone matrix (DBM) is processed allograft bone and is considered minimally processed tissue.

Human cells, tissues, or cellular or tissue-based products (HCT/Ps) Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Note this is the term preferred by FDA.

Mesenchymal precursor cells (MPCs) are perivascularized tissues in the body, including bone marrow, dental pulp and adipose tissue. MPCs are precursors of all multi-potential fibroblastoid Colony Forming Units (CFU-F), suggesting that they give rise to all the mesenchymal lineage stem cells in the tissues they reside in, and which can differentiate under appropriate stimuli into bone, fat and cartilage.

Mesenchymal stem cells (MSCs) are a prototypical adult stem cell with capacity for self-renewal and differentiation with a broad tissue distribution. Initially described in bone-marrow, MSCs have the capacity to differentiate into mesoderm and nonmesoderm-derived tissues including osteoblasts (bone cells), chondrocytes (cartilage cells), and adipocytes (fat cells).

Osteonecrosis/avascular necrosis is bone death cause by poor blood supply to the area. It is most common in the hip and shoulder, but can affect other large joints such as the knee, elbow, wrist and ankle.

Regenerative medicine is an emerging field of medical science that aims to regenerate, repair or replace damaged tissue and organs. The U.S. National Institute of Health has stated that regenerative medicine is the process of creating functional tissue to repair and replace tissue or organs, which have lost their function due to damage, congenital defects, disease and age.

Stem cells are cells with the ability to divide for indefinite periods in culture and to give rise to specialized cells. They can be taken from the bone marrow, peripheral bloodstream, or from umbilical cord blood.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

Codes

Descriptions

20999

Unlisted procedure, musculoskeletal system, general

22899

Unlisted procedure spine

27599

Unlisted procedure, femur or knee

38220

Bone marrow aspiration

38205

Blood derived hematopoietic progenitor cell harvesting for transplantation, per collection allogeneic

38206

Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous

38230

Bone marrow harvesting for transplantation; allogeneic

38232

Bone marrow harvesting for transplantation; autologous

38240

Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

38241

Autologous transplantation

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. American Academy of Orthopaedic Surgeons (AAOSTreatment of osteoarthritis of the knee Evidence-based guideline 2nd edition. 2013.
  2. Chen, A. K. L., Reuveny, S., & Oh, S. K. W. (2013). Application of human mesenchymal and pluripotent stem cell microcarrier cultures in cellular therapy: achievements and future direction. Biotechnology advances31(7), 1032-1046.
  3. Chew, E., Prakash, R., & Khan, W. (2017). Mesenchymal stem cells in human meniscal regeneration: a systematic review. Annals of medicine and surgery.
  4. De Bari, C., & Roelofs, A. J. (2018). Stem cell-based therapeutic strategies for cartilage defects and osteoarthritis. Current opinion in pharmacology, 40, 74-80.
  5. ECRI Institute (2012). Health Technology Forecast. Autologous and Allogeneic Mesenchymal Stem Cell Therapy for Treating Osteoarthritis.Plymouth Meeting, PA: ECRI Institute.
  6. ECRI Institute (2013). Emerging Technology Evidence Report. Autologous Mesenchymal Stem Cells for Treating Knee Osteoarthritis. Plymouth Meeting, PA: ECRI Institute.
  7. ECRI Institute (2013). Product Brief. AlloStem Stem Cell Bone Growth Substitute (AlloSource) for Orthopedic procedures. Plymouth Meeting, PA: ECRI Institute
  8. Goldschlager, T., Ghosh, P., Zannettino, A., Williamson, M., Rosenfeld, J. V., Itescu, S., & Jenkin, G. (2011). A comparison of mesenchymal precursor cells and amnion epithelial cells for enhancing cervical interbody fusion in an ovine model. Neurosurgery68(4), 1025-1035.
  9. Hass, R., Kasper, C., Böhm, S., & Jacobs, R. (2011). Different populations and sources of human mesenchymal stem cells (MSC): a comparison of adult and neonatal tissue-derived MSC. Cell Communication and Signaling9(1), 12.
  10. Hayes, Inc. Hayes Health Technology Brief. Autologous Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Treatment of Nonunion of the Lower Extremity. Lansdale, PA: Hayes, Inc.; November, 2014. Reviewed October, 2016.
  11. Hayes, Inc. Hayes Medical Technology Directory Report. Autologous Stem Cell Therapy for Treatment of Avascular Necrosis of the Hip. Lansdale, PA: Hayes, Inc.; December, 2015. Reviewed November, 2016
  12. Hayes, Inc. Hayes Medical Technology Directory Report. Stem Cell Therapies for Joint Pain. Lansdale, PA: Hayes, Inc.; July, 2018.
  13. Hayes, Inc. Hayes Medical Technology Directory Report. Concentrated Bone Marrow Aspirate for Spinal Surgery. Lansdale, PA: Hayes, Inc.; March, 2016. Reviewed February, 2017.
  14. Jevotovsky, D. S., Alfonso, A. R., Einhorn, T. A., & Chiu, E. S. (2018). Osteoarthritis and stem cell therapy in humans: a systematic review. Osteoarthritis and cartilage
  15. Jin, H. J., Bae, Y. K., Kim, M., Kwon, S. J., Jeon, H. B., Choi, S. J., ... & Chang, J. W. (2013). Comparative analysis of human mesenchymal stem cells from bone marrow, adipose tissue, and umbilical cord blood as sources of cell therapy. International journal of molecular sciences14(9), 17986-18001.
  16. Pas, H. I., Winters, M., Haisma, H. J., Koenis, M. J., Tol, J. L., & Moen, M. H. (2017). Stem cell injections in knee osteoarthritis: a systematic review of the literature. Br J Sports Med, bjsports-2016.
  17. Vallone, V. F., Romaniuk, M. A., Choi, H., Labovsky, V., Otaegui, J., & Chasseing, N. A. (2013). Mesenchymal stem cells and their use in therapy: what has been achieved?. Differentiation85(1), 1-10.
  18. Vangsness, C.Thomas, Farr J., Boyd J., Dellaero C., Mills R. and LeRoux-Williams, M (2014).Adult Human Mesenchymal Stem Cells Delivered via Intraarticular Injection to the Knee Following Partial Medial Meniscectomy; Journal of Bone and Joint Surgery,Volume 96, Issue 2, Pages 90-98
  19. Wang, Y., Shimmin, A., Ghosh, P., Marks, P., Linklater, J., Connell, D. ... & Cicuttini, F. M. (2017). Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial. Arthritis research & therapy, 19(1), 180.
  20. Yamasaki, S., Mera, H., Itokazu, M., Hashimoto, Y., & Wakitani, S. (2014). Cartilage repair with autologous bone marrow mesenchymal stem cell transplantation: review of preclinical and clinical studies. Cartilage5(4), 196-202.

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Policy activity

  • 09/08/2014 - Date of origin
  • 09/26/2017 - Effective date
Review date
  • 08/2018

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