Allograft Injection for Degenerative Disc Disease

POLICY NUMBER

A.7.01.166

DESCRIPTION

Degeneration of the intervertebral discs is commonly observed in imaging and has been proposed to be a source of back pain. In order to treat the observed changes in the discs, cellular therapies such as mesencyhmal stem cells are being studied. One of these cellular therapies involves the intradiscal injection of a mixture of nucleus pulposus allograft and viable cells into the degenerated disc.

Degenerative Disc Disease

Back pain is a common condition in adults. Most episodes of back pain are self-limited and will resolve within one 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. 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. 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.

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 X 10⁶ 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, which was then updated in 2020.

HCT/Ps are defined as human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. If an 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.

An HCT/P is regulated solely under section 361 of the Public Health Service (PHS) Act and Title 21 Code of Federal Regulations Part 1271 if it meets all of the following criteria:

1. "The HCT/P is minimally manipulated;

2. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;

3. The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

4. Either:

   1. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or

   2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:

      1. Is for autologous use;

      2. Is for allogeneic use in a first-degree or second-degree blood relative; or

      3. Is for reproductive use."

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." Amirdelfan and colleagues (2021) published results of a multicenter, randomized, controlled study of rexlemestrocel-L in 100 individuals with degenerative disc disease (NCT01290367). Additionally, in March of 2025, 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). This trial has been reviewed by the FDA's Office of Tissues and Advanced Therapies (OTAT). Based on the 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.

POLICY

Injection of allograft into the intervertebral disc for the treatment of degenerative disc disease is considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

03/15/2022: New policy added. Approved by Medical Policy Advisory Committee.

06/21/2022: Policy description updated regarding a randomized control study of rexlemestrocel-L in individuals with degenerative disc disease. Policy statement unchanged.

07/14/2023: Policy description updated. Policy statement unchanged.

06/13/2024: Policy description updated. Policy statement unchanged.

08/13/2025: Policy description updated. Policy statement unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.166

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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