| Coverage Policy Manual | |
| Policy #: | 2021030 |
| Category: | Surgery |
| Initiated: | June 2021 |
| Last Review: | June 2023 |
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| Allograft Injection for Degenerative Disc Disease | |
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| Description: |
Degenerative Disc Disease
Back pain is a common condition in adults. Most episodes of back pain are self-limited and will resolve within 1 month, but a small percentage will persist and become chronic. Chronic back pain can arise from a variety of etiologies including musculoskeletal pain, vertebral compression fractures, spinal stenosis, disc herniation, or other degenerative changes to the disc that compress the nerve roots and lead to radiculopathy. Age-related degeneration of the intervertebral discs is common and includes numerous biochemical and morphologic changes; the most common of which is loss of glycosaminoglycan and associated loss in water content. Pro-inflammatory molecules increase, while endplate calcification impairs nutrient flow. Together, these lead to an increase in cell death in the nucleus pulposus. Although degenerative changes to the disc are frequently observed on imaging, their contribution to back pain in the absence of radiculopathy is uncertain. Spine imaging, such as magnetic resonance imaging, computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread, but for most people does not cause symptoms. Because many degenerative changes of the disc that are seen on imaging are asymptomatic, identifying the source of the back pain is challenging.
Treatment
Conservative management of back pain is the first-line treatment for most patients. Nonsteroidal anti-inflammatory drugs or other analgesics are used for symptom relief. Duloxetine or tramadol are recommended second-line pharmacologic therapies by the American College of Physicians (Qaseem, 2017). Additionally, modification of activity in conjunction with some form of exercise therapy is frequently prescribed early in the course of symptoms. For patients with persistent nonradicular back pain, guidelines recommend interdisciplinary rehabilitation, which is defined as an integrated approach using physical rehabilitation in conjunction with a psychological or psychosocial intervention (Qaseem, 2017). Opioids may also be prescribed. Although spinal fusion surgery is frequently performed for non-specific back pain with degenerative changes to the disc, surgery has not been shown to be more effective than comprehensive conservative treatment. Cell therapy is being explored as a method to regenerate the intervertebral disc by rehydration, height restoration, and repopulating native cells.
Regulatory Status
VIA Disc Matrix (Vivex Biomedical) is composed of human disc tissue donated from cadavers with viable cells. It consists of a nucleus pulposus allograft suspension that is mixed with a minimum of 6 X106 cryopreserved cells. The cell source and method of processing has not been disclosed, and it is not clear if VIA Disc Matrix meets the U.S. Food and Drug Administration (FDA) criteria for what is considered minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation, Title 21, parts 1270 and 1271. In 2017, the FDA published clarification of HCT/Ps (FDA, 2017).
HCT/Ps are defined as human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If a HCT/P does not meet the criteria below and does not qualify for any of the stated exceptions, the HCT/P will be regulated as a drug, device, and/or biological product and applicable regulations and premarket review will be required.
A HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria:
Rexlemestrocel-L (MPC-06-ID, Mesoblast) is an allogeneic mesenchymal precursor cell (MPC) therapy under investigation for the treatment of chronic low back pain caused by disc degeneration in individuals "who have exhausted conservative treatment options, may have failed epidural steroid injections and have no further treatment option other than invasive and costly surgical intervention” (Mesoblast, 2022). Amirdelfan et al published results of a multicenter, randomized, controlled study of rexlemestrocel-L in100 individuals with degenerative disc disease (NCT01290367) (Amirdelfan, 2021). Additionally, in July of 2021, Mesoblast completed a larger Phase 3 randomized, double-blind, placebo-controlled trial of rexlemestrocel-L in 404 individuals with degenerative disc disease with 36 months of follow-up (NCT02412735). Although this trial is not yet published, it has been reviewed by FDA's Office of Tissues and Advanced Therapies (OTAT). Based on FDA OTAT feedback, as part of their market approval application, Mesoblast plans to conduct an additional US Phase 3 trial with pain reduction at 12 months as the primary endpoint (Mesoblast, 2022).
Coding
Effective January 01, 2021, the following Category III CPT codes may be billed for allograft injection for degenerative disc disease:
0627T Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; first level
0628T Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; each additional level (List separately in addition to code for primary procedure)
0629T Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; each additional level (List separately in addition to code for primary procedure)
0630T Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; each additional level (List separately in addition to code for primary procedure)
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Policy/ Coverage: |
Effective June 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Injection of allograft into the intervertebral disc for the treatment of degenerative disc disease does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, injection of allograft into the intervertebral disc for the treatment of degenerative disc disease is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
The Viable Allograft Supplemented Disc Degeneration in the Treatment of Patients with Low Back Pain (VAST) trial (NCT03709901) is a multicenter RCT that has enrolled 220 patients. Patients who have failed conservative management for 6 months will be treated with the VIA Disc Matrix, placebo injection, or continued non-surgical management in a 3.5:1:1 ratio and followed for up to 36 months. Inclusion criteria are clinical disc degeneration at 1 or 2 levels from L1 to S1 with moderate to severe disability (low back pain >6 mos, ODI >40, VAS >40 mm), and moderate Pfirrmann grading (levels 3 to 6) on MRI. Exclusion criteria are disc protrusion >5 mm, spondylolisthesis >5 mm at any level, and body mass index >35.
Results for the first 24 patients were evaluated for safety at 1 month, with 12 month VAS and ODI of these first participants reported by Beall et al (Beall, 2020). The report included 16 patients treated with the VIA Disc Matrix, 4 patients who received a placebo injection into the intervertebral disc, and 4 individuals who continued with non-surgical management. Cross-over of the non-surgical management group to allograft injection was allowed at 3 months.
No major safety concerns were identified. Adverse events were reported in 6 of 16 (37.5%) participants in the experimental group and 1 of 4 (25%) participants in the placebo injection group. None of the adverse events were considered related to the allograft. It is notable that at 1 month, both injection groups showed similar improvement in ODI and VAS. The conservative management arm did not improve, and all 4 patients in this group crossed over to VIA Disc Matrix at 3 months. At the planned 6 month follow-up, VAS for the 2 injection groups began to diverge, and 1 patient in the placebo control group did not continue in the study and subsequently received the injection of VIA Disc Matrix. Power for the VAST trial is based on 220 patients in the full study and no statistical analysis was performed for these initial safety results. Notably, however, scores on the ODI improved to some extent for both injection groups, suggesting a strong placebo or non-specific effect for this procedure.
For individuals with degenerative disc disease who receive a viable allograft injection, the evidence includes preliminary results from a RCT (VAST trial). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Results from the first 24 patients of a trial on VIA Disc Matrix have been reported. The trial has completed recruitment of 218 of the 220 planned participants, and follow-up will continue for 36 months, with expected completion in January 2022. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
American College of Physicians
In 2017, the American College of Physicians recommended that "For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation. (Grade: strong recommendation, low-quality evidence).
In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence) (Qaseem, 2017)."
North American Spine Society
In 2020, the North American Spine Society, along with 9 other societies, published multidisciplinary evidence-based guidelines on the diagnosis and treatment of low back pain (North American Spine Society, 2020). There were 82 clinical questions that were addressed in the comprehensive evidence review. Regarding degenerative disc disease, the guideline gave a grade A recommendation that provocative discography without manometric measurements correlates with both pain reproduction in the presence of moderate to severe disc degeneration on MRI/CT [magnetic resonance imaging/computed tomography] discography and with the presence of endplate abnormalities on MRI imaging. There was insufficient evidence to make a recommendation for or against the use of intradiscal bone marrow concentrate in patients with discogenic low back pain, and no review of intradiscal allograft injection.
Clinical Trials
The following ongoing/unpublished clinical trials may affect this review.
Ongoing Trials
NCT02412735a
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
Planned enrollment: 404 Completion Date: Mar 2021
NCT03709901a
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain With or Without Intervertebral Disc Herniation - VAST Trial
Planned enrollment: 218 Completion Date: Jan 2022
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Beall et al subsequently published one-year results from all 218 enrolled individuals (Beall, 2021). The study included218 patients with disc degeneration at 1 or 2 levels from L1 to S1 with ODI >40, VAS >40 mm, and Pfirrmann level 3 to 6 on MRI. Results from the first 12 months of the planned 36 months of follow-up did not find statistically significant differences between the active allograft, placebo allograft, and conservative management groups on the co-primary endpoints of mean change on the ODI and VASPI. However, a loss of follow-up of 16.5% of individuals resulted in the trial being underpowered to detect these outcomes.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Amirdelfan K, Bae H, McJunkin T, et al.(2021) Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy. Spine J. Feb 2021; 21(2): 212-230. PMID 33045417 Beall DP, Wilson GL, Bishop R, et al.(2020) VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease. Int J Spine Surg. Apr 2020; 14(2): 239-253. PMID 32355632 Mesoblast.(2022) Single Dose of Mesoblast's Allogeneic Cell Therapy Provides Durable Pain Reduction for At Least Three Years in Patients with Degenerative Disc Disease: Global Newswire. January 11, 2022.https://www.globenewswire.com/news-release/2022/01/12/2365313/0/en/Single-Dose-of-Mesoblast-s-Allogeneic-Cell-Therapy-Provides-Durable-Pain-Reduction-for-at-Least-Three-Years-in-Patients-With-Degenerative-Disc-Disease.htmlAccessed April 9, 2022. North American Spine Society.(2020) Evidence-based clinical guidelines for multidisciplinary spine care: Diagnosis and treatment of low back pain. 2020. https://www.spine.org/Portals/0/assets/downloads/ResearchClinicalCare/Guidelines/LowBackPain.pdf. Accessed April 16, 2021. Qaseem A, Wilt TJ, McLean RM, et al.(2017) Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians . Ann Intern Med. Apr 04 2017; 166(7): 514-530. PMID 28192789 Beall DP, Davis T, DePalma MJ, et al.(2021) Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial. Pain Physician. Sep 2021; 24(6): 465-477. PMID 34554689 Katz NP, Paillard FC, Ekman E.(2015) Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions. J Orthop Surg Res. Feb 03 2015; 10: 24. PMID 25645576 Mesoblast.(2022) Chronic Low Back Pain Due to Disc Degeneration. 2022. https://www.mesoblast.com/product-candidates/spine-orthopedic-disorders/chronic-discogenic-low-back-pain Accessed April 8, 2022. Parker SL, Mendenhall SK, Shau DN, et al.(2012) Minimum clinically important difference in pain, disability, and quality of life after neural decompression and fusion for same-level recurrent lumbar stenosis: understanding clinical versus statistical significance. J Neurosurg Spine. May 2012; 16(5): 471-8. PMID 22324801 U.S. Food and Drug Administration.(2017) Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff. 2017 https://www.regulations.gov/document?D=FDA-2017-D-6146-0003 Accessed April 12, 2021 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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