Response to Comments: Intervertebral Disc Repair

I am writing this letter on behalf of the Society of Interventional Radiology (SIR). Representing more than 8,000 members, SIR’s core purpose and mission is to deliver patient-centered care through image-guided therapy. Interventional radiologists pioneered minimally invasive treatments, which deliver solutions with less risk, pain, and recovery time than traditional surgery. Interventional radiology has revolutionized the practice of modern medicine with the introduction, development, and validation of minimally invasive therapies, many of which have not only replaced invasive procedures but have also offered novel diagnostic and therapeutic solutions where none previously existed.

Interventional radiologists play an increasingly active and important role in the spine care pain management team due to their specialized anatomical discernment during image-guided procedures and their ability to access and navigate catheter devices in confined, often complex, vertebral spaces. Intradiscal therapies aimed at restoring and preserving the native intervertebral disc fall well within the purview of SIR, and we, along with many of our esteemed colleagues, strongly support clinical applications in this area.

As such, we disagree with the proposed LCD for noncoverage of minimally invasive, intradiscal injection therapy for Intervertebral Disc Repair currently covered under code 0627T. The scope of this LCD is too broad by denying coverage for, “all injections for Intervertebral Disc Repair.” There is an accumulating body of clinical evidence demonstrating that VIA Disc^® NP, a commercially available minimally manipulated off-the-shelf product composed of processed human nucleus pulposus tissue allograft, is safe and effective for the treatment of patients with chronic lumbar discogenic pain. We endorse continued coverage of this product.

The recognition of lumbosacral discogenic pain as a unique syndrome distinct from other sources of low back pain and the related establishment of specific ICD-10-CM codes dictate that we increase our efforts to bring safe and effective intradiscal treatments, such as VIA Disc^® NP, to patients rather than deny coverage.

We appreciate your consideration of our viewpoint and the importance of this issue to our membership.

References were provided for review.

Thank you for your comments. To clarify, Category III codes are subject to individual consideration and coverage is determined by medical necessity; therefore, there is no positive or negative coverage policy effective at this time for 0627T. The policy is based on the clinical evidence for treatments for intravertebral disc repair. While we understand that the scope of the LCD is broad, it encompasses a review of available literature regarding this subject. The evidence section of the LCD has been updated to include VIA Disc^® NP and explain VIA Disc has been removed from the market. Additionally, the rationale for decision has been expanded to explain that there is insufficient evidence to support the coverage of VIA Disc^® NP which does not meet the definition of reasonable and necessary. Should there be new peer reviewed published literature, we would be happy to entertain it during a reconsideration request. The cited literature by Lorio et al. and by Lopera, are opinion pieces/perspectives/musings or editorial updates and as such are not part of literature review as mandated by CMS.

The following comment was received from multiple stakeholders.

As an Interventional Pain Management physician, I strive to find the most effective solutions for my patients and their needs. For those dealing with Discogenic Low Back Pain today, VIA Disc^® NP provides an option that stands out from more traditional treatments in that it addresses the root cause of dehydration in the disc rather than merely masking symptoms.

With VIA Disc^® NP, my practice can bring new hope to individuals suffering from discogenic low back pain. By offering such an innovative solution in our community, I am confident we can improve many patients' quality of life and overall outcomes.

By continuing to cover VIA Disc^® NP, you can give peace of mind and provide key treatment options for those struggling with discogenic low back pain. In addition, this course of action will offer a pathway toward potentially reducing their pain – an invaluable aid in the fight against DLBP that affects so many people.

The initial findings of the VIA Disc^® NP Pilot Study have been incredibly encouraging: from decreased pain to improved function, there is substantial reason for optimism. VIA Disc^® NP could offer a lifeline for our patients and open up new possibilities for treating these painful disc-related conditions.

A Prospective Open-label Multi-center Study of Nucleus Pulposus Allograft: Provisional Results of a 35-patient Pilot Study:

• 73% of all subjects achieved ≥15 pt decrease in ODI & 50% decrease in pain;
• >60% ODI improvements in patients with Modic 2 changes;
• NP allograft is similar to cellular allografts’ published data.

ISASS recently approved VIA Disc^® NP, a minimally invasive treatment approach to relieve discogenic low back pain. This endorsement underlines the capabilities of this innovative option.

Our practice is devoted to delivering the utmost care for those affected by discogenic low back pain. We would be honored to offer VIA Disc^® NP as 1 of our treatment options, taking advantage of its innovative technology. To summarize, I feel strongly that VIA Disc^® NP should be covered.

Thank you for your comments. The results of the 35-patient pilot study were not published at the time the LCD was written. To be included as evidence, the study must be published in a peer reviewed journal. The 29-patient pilot study was published 12/2/2024. The LCD has been updated to include review of this study.

We are unable to add the ISASS recommendation to the LCD, because this was not included with the comments. We cannot locate a published statement from ISASS, other than an opinion piece. Nonetheless, even if we had the statement, it does not address the short-comings of the current literature; therefore, it does not change the current non-coverage position. If future literature is developed, this can be reconsidered through the LCD reconsideration process.

As an Interventional Pain Management physician, I am writing to provide comments on the VIA Disc^® NP allograft.

VIA Disc^® NP has been instrumental in allowing patients to experience a better quality of life by supporting their spine health through cushioning the intervertebral disc. Discogenic patients are often trapped in a seemingly unending cycle of care due to conservative treatments that temporarily alleviate pain instead of addressing the underlying issue. Spine surgery may become the only viable solution as their condition continues deteriorating.

In treating patients with VIA Disc^® NP, I have seen the high clinical impact of this novel, nucleus pulposus tissue allograft and I believe there is sufficient evidence that shows improvement in health outcomes. The large majority of the patients I have treated with VIA Disc^® NP have experienced pain relief and improvement in function.

Furthermore, as stated by Dr. Lorio, via the ISASS endorsement of VIA Disc^® NP, “Although axial low back pain represents the largest malady impacting mankind and the workforce, it remains neglected by some payors in part due to a plethora of non-granular ICD-CM-codes.”

Lastly, the interim findings from the study below are promising and continue to bolster the already groundbreaking data from Cleveland Clinic on VIA Disc^® NP.

Shrif Costandi MD, Nagy Mekhail MD, PhD, Peter Yassa MD, Heather Rogers, BA, RPSGT Pain Management Department, Cleveland Clinic, Cleveland, OH, Evidence-Based Pain Medicine, Cleveland Clinic, Cleveland, OH; A Prospective Open-label Multi-center Study of Nucleus Pulposus Allograft: Provisional Results of a 35-patient Pilot Study.

• NRS scores improved from 7.3 to 3.96 to 3.1 to 3 at 1,3 and 6 months respectively. Functionality, as measured by ODI, improved from 53.9 to 28.6 to 24.4 to 38 at 1, 3, and 6 months, respectively.
• The proportion of 21 subjects at 3-months achieving a clinically significant change of ≥50% improvement in NRS and ≥15-point improvement of ODI was 71% for both.

By leveraging the novel VIA Disc^® NP allograft, countless patients suffering from Discogenic Low Back Pain have seen dramatic improvements in their quality of life. Early results from the NP Pilot Study and the endorsement from ISASS confirm that this treatment is more than deserving to be covered by your MAC’s jurisdiction so it can benefit even more lives across the region. I highly recommend its recognition due to my personal experience observing how successful VIA Disc^® NP has been for my patients living with discogenic low back pain.

Thank you for your comments. The results of the 35-patient pilot study were not published at the time the LCD was written. To be included as evidence, the study must be published in a peer reviewed journal. The 29-patient pilot study was published 12/2/2024. The LCD has been updated to include review of this study.

We are unable to add the ISASS recommendation to the LCD, because this was not included with the comments. We cannot locate a published statement from ISASS, other than an opinion piece. Nonetheless, even if we had the statement, it does not address the short-comings of the current literature; therefore, it does not change the current non-coverage position. If future literature is developed, this can be reconsidered through the LCD reconsideration process.

The following comment was received from multiple stakeholders.

It has been brought to the attention of the American Society of Spine Radiology (ASSR) and the Pacific Spine & Pain Society (PSPS) that there is a proposed LCD for noncoverage of minimally invasive intradiscal injection therapy as a treatment for patients diagnosed with discogenic low back pain. We disagree with this proposal. Of particular concern is the opening statement that “This is a non-coverage policy for all injections for Intervertebral Disc Repair.” We acknowledge that there is a range of efficacy among the 9 products included in the LCD, but we contend that a blanket non-coverage policy is too broad as some of these products are considered to have valuable clinical utility among our constituency of spinal diagnosticians and interventional pain physicians in the management of patients with lumbar discogenic pain.

We have noted the recent issuance of specific International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for lumbosacral discogenic pain associated with degenerative disc disease by the National Center for Health Statistics (NCHS). We believe the recognition of discogenic pain as a distinct syndrome is not only long overdue but underscores the importance of utilizing clinically effective intradiscal interventions to treat this patient group and potentially delay costly and invasive surgical interventions.

As a global society of spine specialists devoted to advancing spinal imaging and intervention, ASSR is dedicated to improving treatment and quality of life of those with back and neck pain and spine pathology. We maintain a keen interest in the pathoetiology and treatment of intervertebral disc degeneration. One of our esteemed members, has shared a pre-publication transcript of an in-press article reporting on 29 patients with lumbar discogenic pain treated with a single intradiscal injection of VIA Disc^® NP. In addition to significant improvements in back pain and function in excess of 50% over baseline, we were impressed that 64% of patients reported a pain score ≤ 3 6 months after injection which represents the patient acceptable symptom state.

Additionally, there is a growing body of evidence supporting the clinical effectiveness of VIA Disc^® NP, a commercially available, off-the-shelf nucleus pulposus allograft product regulated as a tissue for homologous use. We were disappointed to find that VIA Disc^® NP, despite its considerable clinical utilization in the U.S., was not considered under the section entitled “Allogenic Cellular/Tissue-Based Product”. Rather, this section was limited to a summary of a related product, VIA Disc^®, which is not commercially available. This omission does not allow public comment on the most viable and widely used intradiscal treatment intervention for discogenic pain in current therapeutic practice, VIA Disc^® NP.

In closing, ASSR and PSPS reiterates that the scope of this LCD is too broad by encompassing in its proposal for noncoverage of ALL intradiscal injection products used for intervertebral disc repair. Some of these products have limited clinical use and/or indications outside the area of lumbar discogenic pain. Others, such as VIA Disc^® NP, have demonstrated tremendous clinical potential for ameliorating symptoms associated with discogenic low back pain. We firmly believe that denying coverage for new technologies with a satisfactory safety profile and a growing body of corroborative clinical evidence of efficacy hampers the collection of real-world data to support future Category 1 reimbursement coding classification.

References were provided for review.

Thank you for your comments. While we understand that the scope of the LCD is broad, it encompasses a review of available literature regarding this subject. Should there be new peer reviewed published literature, we would be happy to entertain it during a reconsideration request. The results of the 35-patient pilot study were not published at the time the LCD was written. To be included as evidence, the study must be published in a peer reviewed journal. The 29-patient pilot study was published 12/2/2024. The LCD has been updated to include review of this study. The LCD has also been updated to reflect that VIA Disc^® is no longer commercially available. However, despite promising preliminary evidence for VIA Disc^® NP this study does not have sufficient sample size to determine if the product is effective and improves outcomes. The data is also limited to short term follow-up, lack of controls or randomization and risk of bias resulting in low certainty evidence for clinical effectiveness.

The cited literature by Lorio et al. and by Lopera, are opinion pieces/perspectives/musings or editorial updates and as such are not part of literature review as mandated by CMS. The literature by Abel is a review of Imaging of Discogenic pain, and as such is not affected by the LCD and was not reviewed. The literature from Elmounedi is a review of current therapies and was reviewed but not cited. Future evidence can be submitted through the LCD reconsideration process.

The following comment was received from multiple stakeholders.

The practice of pain medicine has changed significantly over the past 7-10 years. As scrutiny of opioid prescribing has increased, and our knowledge about the long-term harms of these medications has increased, our need for other treatments has grown. These options have grown, allowing physicians to provide improved care for patients with chronic back pain.

As an Interventional Pain Management physician, I take great care to identify my patients' most effective treatment options. By far, VIA Disc^® NP stands out as an unrivaled solution for those dealing with discogenic low back pain. This groundbreaking technology addresses disc degeneration directly through the hydration of nucleus pulposus tissue.

People suffering from discogenic low back pain now have access to an outstanding treatment for their back pain in the form of intradiscal supplementation. This therapy is the injection of allograft, not stem cells. The NP Pilot study, along with the endorsement from ISASS, has shown incredibly positive clinical progress. This is a strong testament to the effectiveness of VIA Disc^® NP in treating discogenic low back pain. This therapy is included in the guidelines for the treatment of axial low back pain from several of our national societies.

“ISASS recognizes VIA Disc^® NP’s functional and socio-economic importance in safely supplementing degenerated intervertebral discs for patients suffering from discogenic low back pain as published in IJSS, which is the official scientific journal of ISASS.”

Patients have a right to receive the highest standard of care, and as such I respectfully urge you to reconsider your decision to issue a non-coverage LCD. Allowing access to VIA Disc^® NP will enable my practice to reach an unparalleled level of excellence in patient treatment options. I hope you will give this request the serious consideration it deserves.

Thank you for your comments. There was no submitted literature with these comments, including real world data for Via Disc^® NP or societal support. There is no evidence that Via Disc^® NP reduces opioid use or surgical intervention. If additional evidence is developed it can be submitted via the reconsideration process.

The International Society for the Advancement of Spine Surgery (ISASS) is writing to express concern regarding the proposed LCD for noncoverage of minimally invasive, intradiscal injection therapy as a treatment for individuals diagnosed with discogenic low back pain. ISASS is a premier specialty society committed to enhancing the science and practice of nonoperative and surgical interventions to restore and improve function to the spine. We represent a broad multi-disciplinary membership of scholars, surgeons and other spine care practitioners with a particular interest in arresting the degeneration of the spine by, first and foremost, restoring and preserving the natural anatomical structures. ISASS was founded around the concept of motion preservation, thus, our keen interest and understanding of this issue.

The intervertebral disc is the most intensively studied and characterized structure in the human spine and is now recognized as the primary antecedent and precipitator of all subsequent degenerative changes across the entire vertebral motion segment. ISASS was at the forefront in recently establishing specific universal diagnostic coding (ICD-10-CM) for lumbosacral discogenic pain associated with degenerative disc disease. Consequently, there is now consensus regarding the specific diagnostic characteristics of discogenic low back pain and its differentiation from other sources of back pain such as neurocompressive or vertebrogenic.

ISASS is supportive of the underlying precepts of this code (0627T) and was instrumental in its establishment. We remain equally supportive of using this tracking code to collect valuable real-world data about utilization and clinical adoption of new intradiscal technologies that have the potential to delay or avert surgical intervention. While the proposed LCD co-mingled 9 different agents (products) that may or may not have established safety and effectiveness for the minimally invasive treatment of chronic lumbar discogenic pain, only nucleus pulposis (NP) allograft (VIA Disc^® NP, Vivex^® Biologics, Miami, FL) is being utilized and evaluated in a manner consistent with methodological standards necessary to support U.S. regulatory requirements. This commercially available product is an off the-shelf processed human NP tissue allograft intended to supplement degenerated intervertebral discs. It is minimally manipulated material manufactured under strict quality controls and regulated as a “tissue” solely under section 361 of the Public Health Service (PHS) Act.

As noted in the proposed LCD, the VAST trial provides a “fair” level of methodological quality to serve as a basis for establishing efficacy for intradiscal NP as a treatment for lumbar discogenic pain. ISASS would expand this assessment to recognize that the validity of the findings are plausible due to several factors: large sample size of participants (n=218), satisfactory adherence to follow-up, and clinically-significant improvements despite an active control comparison group (i.e., saline injection). Importantly, the occurrence of product- or procedure-related adverse events was low (3.5%) providing assurance of the safety of the procedure/product when used by properly-trained interventionalists. The product studied in this trial (VIA Disc^®) consisted of disc allograft minimally processed from human cadaver nucleus pulposus, lyophilized and ground. A minimum of 6 x 106 cells suspended in 1 ml of non-DMSO cryoprotectant was provided in a separate cell vial, and the cell and tissue allograft components were mixed with ≈1 ml of saline for delivery into the level of treatment. This product (VIA Disc^®) is currently not commercially available.

The current commercially available NP product (VIA Disc^® NP) contains only the processed allograft NP tissue without the addition of live cells. Specifically, it is disc allograft minimally processed from human cadaver nucleus pulposus that is lyophilized and ground to particles that are ≤ 106 microns and aliquoted to 100 mg of volume for a single unit. The tissue is reconstituted with 2 ml of sterile saline for delivery into the disc level of treatment.

There is a rapidly growing compendium of clinical data regarding the use of VIA Disc^® NP in the treatment of lumbar discogenic pain that was not included in the proposed LCD. The most recent clinical results are summarized from 3 studies and include patients spanning a large age-range. Beall et al. reported on 29 patients (mean age, 44 ± 13 years) with symptoms of lumbar discogenic pain and corresponding imaging evidence of disc degeneration treated with a single intradiscal injection of NP. The average back function and pain severity improvements between baseline and 6 months were 55%, and 53%, respectively (p<0.001). A minimal clinically important difference (MCID) of ≥ 30% improvement over baseline was achieved in 79% and 68% of patients for back function and pain, respectively. At 6 months, 64% of patients had a pain score ≤ 3.

In an older Medicare-eligible population of 19 patients (age range: 65-76 years) with lumbar discogenic pain, Azeem et al. reported a 76% and 66% improvement in back pain and function, respectively, at 6 months following a single NP injection. Corresponding responder rates for substantial clinical benefit (≥ 50% improvement) for back pain and function were 86% and 71%.

Evaluating the back pain and functional outcomes in a heterogeneous population of 21 patients (age range: 41-73 years) with lumbar discogenic pain treated with NP in a real-world clinical setting, Lin et al. reported that 86% of patients reported some level of satisfaction with the procedure, of which 71% reported “extreme satisfaction”. Additionally, there was an average 58% improvement in back pain severity at the latest follow-up assessment (range: 4-24 months).

Taken as a whole, these recent study findings corroborate and extend the results from the VAST trial. The trend toward clinically significant improvements in back pain and function appear to be consistent across studies and age groups.

ISASS would like to highlight that several of the products included in this LCD are not considered viable treatments for discogenic pain. The supporting literature cited suggests that these products are primarily used for conditions such as disc herniation with radiculopathy (neurocompressive pain) which is a different spinal condition from discogenic pain. This inclusion of products outside the intervertebral disc repair indication, or those with limited clinical use, may dilute the findings related to safe and effective interventions such as VIA Disc^® NP.

After reviewing the above comments, it is hoped that you will consider revising the proposed LCD to reflect the above clarifications, new evidence and provide coverage accordingly.

References were provided for review.

Thank you for your comments. While we understand that the scope of the LCD is broad, it encompasses a review of available literature regarding this subject. Should there be new peer reviewed published literature, we would be happy to entertain it during a reconsideration request. While there may well be a “rapidly growing compendium of clinical data regarding the use of VIA Disc^® NP in the treatment of lumbar discogenic pain”, this data does not meet the criteria used by CMS for literature to support an LCD. Proceedings from annual meetings such as those from Azeem et al. and Lin et al., do not meet CMS requirements for literature to support an LCD. The other cited literature has already been discussed in previous responses, except for the molecular review article by Fine et al., which is more germane to a distinction between osteoarthritis and intervertebral disc degeneration.

The results of the 35-patient pilot study were not published at the time the LCD was written. To be included as evidence, the study must be published in a peer reviewed journal. The 29-patient pilot study was published 12/2/2024. The LCD has been updated to include review of this study.

The American Society of Pain & Neuroscience (ASPN) is currently comprised of more than 3,000 physicians from the specialties of Anesthesiology, Neurology, Neurosurgery, Orthopedics, Physical Medicine and Rehabilitation, Preventive Medicine and Public Health. Our membership comprises a significant proportion of physicians who perform intradiscal and intervertebral procedures.

On behalf of ASPN, we write to provide comments on the proposed LCD-Intervertebral Disc Repair, as we believe some of the outlined therapies play a well-defined and integral role in the treatment of those patients with chronic discogenic axial low back pain. Intradiscal VIA Disc^® NP allograft treatment of painful, degenerative disc disease is the primary treatment used by a majority of our members, and this treatment demonstrates that it is a safe and effective minimally invasive intervention. It is imperative that we remain unhampered in our ability to collect valuable real-world data about utilization and clinical adoption of VIA Disc^® NP under code 0627T. As such, we disagree with the premise proposed in the LCD for noncoverage of “all injections for Intervertebral Disc Repair.”

Interventional Pain Medicine is in an unprecedented time of innovation and growth.

1. As a society we have been committed to this advancement and responsible utilization of minimally invasive spine procedures, regenerative medicine, and other areas of spine care via mutual collaboration with physician members, scientists, governmental agencies, payers, centers of higher education, and other medical societies.
2. As lumbar discogenic pain presents a significant treatment challenge, ASPN recognizes a resurgence of innovative interventional therapies that aim to restore and preserve the natural structure and function of the diseased vertebral segment.
3. This includes the establishment of unique ICD-10-CM codes that clearly define and differentiate lumbosacral discogenic pain.
4. Minimally-invasive intradiscal injectable treatments represent an enormous opportunity to improve spine care by delaying or avoiding surgical intervention and enhancing quality of life in patients with discogenic back pain. At our recent annual society meeting in July 2024, we highlighted several studies focusing on intradiscal therapies to include the study, “Regenerative Therapeutics: The New Frontier,” a study by Dr. Nomen Azeem that was selected for the ASPN Top Abstract Presentation.
5. Dr. Azeem presented the results of 19 Medicare-eligible patients (age range: 65-76 years) with lumbar discogenic pain and reported a 75% improvement in axial back pain severity at 6 months following a single VIA Disc NP injection. This resulted in 85% of patients reporting an improvement in pain of ≥ 50% compared to pre-injection levels which corresponds with substantial clinical benefit. (Also included at our annual society meeting was a poster presentation by Dr. Ellen Lin and colleagues of 21 patients treated with VIA Disc^® NP in a private practice setting.)
6. There was an average 58% improvement in back pain severity with 86% of patients reporting some level of satisfaction with the procedure, of which 71% reported “extreme satisfaction”. Showcasing VIA Disc^® NP at our annual society meeting emphasizes our endorsement and advocacy for maintaining adequate coverage for this product and procedure so that patients with discogenic low back pain can benefit.

ASPN was created to harness the talents of the brightest minds in our profession. We very much appreciate your attention to this matter.

References were provided for review.

Thank you for your comments. Proceedings from annual meetings such as those from Azeem et al. and Lin et al., do not meet CMS requirements for literature to support an LCD. The article by Hua is a review article of a variety of minimally invasive interventional therapies for pain and is not specific to injections into the intervertebral disc. Therefore, these were not added to the LCD as supporting evidence.

On behalf of Vivex^® Biologics, Inc. (Vivex^®), I appreciate the opportunity to submit the below comments regarding the proposed LCD, Intervertebral Disc Repair and associated draft article, Billing and Coding: Intervertebral Disc Repair.

Vivex^® believes there are significant inaccuracies and troubling issues (legal, factual, and medical) contained in the Proposed LCD and Draft Article. The most problematic element of the Proposed LCD is that the data discussed in it, and upon which you have based your non-coverage determination, is related to a formerly marketed and different product, VIA Disc^®. This product, an allogeneic disc matrix that contained living cells, was voluntarily withdrawn from the market in 2021. A distinct Vivex^® product currently on the market, administered using CPT^® codes referred to in the Draft Article, is VIA Disc^® NP, which is a different human tissue product. Unlike VIA Disc^®, as explained further below, VIA Disc^® NP is allograft nucleus pulposus indicated for implantation to supplement inadequate native nucleus pulposus and contains no living cells. As such, the Proposed LCD discusses non-coverage for a product that has been off the market for 3 years (VIA Disc^®), yet could result in non-coverage for a different product (VIA Disc^® NP). Non-coverage of VIA Disc^® NP as a result of this process also is impermissible because the product does not involve intervertebral disc repair. For these and other reasons detailed further below, should a final LCD and billing article be issued, we request the Medicare Administrative Contractors (MAC) make clear that the final policy does not apply to VIA Disc^® NP and that the product remains available for coverage.

In light of these concerns, we offer the following summary of our comments and recommendations on the Proposed LCD and Draft Article, which are discussed in more detail below:

• The Proposed LCD, insofar as it would lead to non-coverage for VIA Disc^® NP, does not meet applicable statutory or Centers for Medicare & Medicaid Services (CMS) guidance requirements found in the Medicare Program Integrity Manual (MPIM) because it does not contain a proposed determination and a discussion of evidence for that “particular item.” The closest the Proposed LCD comes is addressing evidence for and coverage of VIA Disc^®, a different product that has not been on the market since 2021. Notwithstanding the similarities of their names, VIA Disc^® and VIA Disc^® NP have distinctive and unique characteristics making analysis of 1 irrelevant to the analysis of the other.
• VIA Disc^® NP is not an “intervertebral disc repair” item and as such, the sweeping application of this Proposed LCD to it is inappropriate.
• The Proposed LCD and Draft Article are inconsistent in that the Proposed LCD proposes non-coverage for all intradiscal injection therapies, whereas the Draft Article identifies as non-covered codes for only some of the services that the Proposed LCD would not cover.
• We also note that unlike the other products addressed in the Proposed LCD for which the lack of physician specialty society support is noted, VIA Disc^® NP has overwhelming support from such societies as a safe and effective solution for discogenic back pain.

I. Background

The Proposed LCD discusses 9 different items/classes of items, dedicating a specific section (bolded header) in the document to each. One such section is for “Allogenic Cellular/Tissue-Based Product” and this section is devoted solely to a discussion and description of VIA Disc^® Matrix (i.e., VIA Disc^®), an allogeneic disc matrix used in the intervertebral disc. VIA Disc^® consisted of 2 key allograft components derived from human cadaveric donor tissue – (1) intervertebral disc tissue particulate and (2) spine-derived cells. VIA Disc^® provided a scaffold for additional water absorption capacity, expected to improve hydrostatic pressure on the disc, and included donor cells to aid in localized healing. The product was injected percutaneously into an intervertebral disc in a procedure reported using a CPT code in the 0627T-0630T range. The evidence presented in this section of the Proposed LCD is a discussion of 1 study – the VAST trial, which is a single study pertaining to VIA Disc^®. VIA Disc^® has not been on the market since June of 2021.

The product Vivex^® currently markets is VIA Disc^® NP. VIA Disc^® NP is a distinct and separately marketed product from VIA Disc^®, and these products have different compositions. VIA Disc^® NP is composed solely of 1 allograft component: processed human cadaveric nucleus pulposus tissue isolated from the intervertebral disc. The resulting allograft is reconstituted with sterile saline and administered to the recipient using a spinal needle, in the procedures described by CPT codes 0627T – 0630T. It does not contain living cells and does not contain the “minimum of 6 X 10⁶ cryopreserved cells” identified in the Proposed LCD.

As is clear from above, the Proposed LCD only analyzes VIA Disc^® and only reviews evidence related to VIA Disc^®. Unfortunately, despite the fact that the VAST trial only studied VIA Disc^®, the Proposed LCD at times conflates VIA Disc^® and VIA Disc^® NP, stating for example that “there were no statistically significant differences between Via Disc^® NP and placebo (saline) treatment groups” (emphasis added). Except the VAST trial did not study VIA Disc^® NP; in fact, VIA Disc^® NP did not even exist and was not on the market at the time of the study.

In brief, the Proposed LCD discusses a product that is no longer marketed (VIA Disc^®) and the coverage determination proposed therein is based on a single study of the prior product.

II. The Proposed LCD, insofar as it would establish non-coverage for VIA Disc^® NP, does not meet requirements of the law and Medicare Program Integrity Manual because it does not contain a proposed determination and a discussion of evidence for that particular item.

As established above, the Proposed LCD only addresses coverage for, and evidence related to, VIA Disc^®. Yet, because the Proposed LCD mistakenly refers to VIA Disc^® NP and is a “non-coverage policy for all injections for Intervertebral Disc Repair,” and since the Draft Article proposes non-coverage for the procedure in which VIA Disc^® NP is injected, the Proposed LCD and Draft Article, if finalized as is, would incorrectly lead readers to believe that they establish non-coverage for VIA Disc^® NP despite neither the product nor its evidence being analyzed or discussed. This is contrary to the mandates of the law and the MPIM, which together require MACs to support a coverage determination for each particular item with evidence related to that item, thereby permitting the public an opportunity to meaningfully participate in the coverage assessment for that particular product.

The law defines an LCD as a determination by a contractor with respect to “whether or not a particular item or service is covered” on a jurisdiction wide basis. Further, the MPIM requires that “in every proposed and final LCD, the MAC must summarize the evidence that supports coverage . . . or noncoverage. At a minimum, the summary should include . . . a complete description of the item or service under review [and] a narrative that describes the scientific evidence supporting the clinical indications for the item or service.” As the definition of LCD means a determination as to “whether or not a particular item or service is covered,” the MAC must support the determination as to each particular item with evidence on that item.

The public comment process is a foundational component of the LCD development process that MACs must utilize, by both the law and CMS guidance. Yet contrary to these requirements, the Proposed LCD and Draft Article may be read as leading to non-coverage for VIA Disc^® NP while only providing evidence and discussion of VIA Disc^®, a product that has not been marketed for more than 3 years, thereby failing to provide the public with a meaningful opportunity to comment on the evidence supporting coverage for VIA Disc^® NP. As such, we feel you may not finalize this coverage policy to apply to VIA Disc^® NP. Any coverage policy that purports to apply to VIA Disc^® NP without first proposing an evidence review of VIA Disc^® NP is contrary to the requirements of law and mandatory CMS guidance.

Accordingly, the MAC must ensure that any final LCD issued clearly states that it does not include VIA Disc^® NP within the scope of any non-coverage policy of the final decision. To that end, in part, the MAC must revise the blanket statement that “all injections” are subject to a non-coverage policy, because the policy cannot apply to the VIA Disc^® NP injection. Moreover, the MAC should use the billing and coding article vehicle to state that coverage for VIA Disc^® NP remains available for coverage on a claim-by-claim basis.

III. VIA Disc^® NP is not an intervertebral disc repair product and is not within the scope of this LCD.

The Proposed LCD has a clear scope: Intervertebral Disc Repair. That is the title of the Proposed LCD and it is part of the seminal statement at the start of the document: “This is a non-coverage policy for all injections for Intervertebral Disc Repair.” As such, only products involved in intervertebral disc repair can fall within the scope of the Proposed LCD or a subsequent final LCD. However, VIA Disc^® NP is not an intervertebral disc repair product, but rather a product that supplements a patient’s own nucleus pulposus tissue. VIA Disc^® NP is furnished to supplement native nucleus pulposus tissue when the patient’s own volume of tissue is insufficient. Vivex^® markets VIA Disc^® NP as a tool to “support natural cushioning function and supplement tissue loss in the intervertebral disc.” VIA Disc^® NP is not intended to repair the intervertebral disc, but rather as an important tool to reduce pain and improve function through support and supplementation of the patient’s own native, but inadequate, tissues.

Repair and supplementation are distinct functions. Per the Food and Drug Administration (FDA), "repair” means the “physical or mechanical restoration of tissues, including by covering or protecting.” “Supplementation” generally means to “add to, or complete,” such as by implanting dermal matrix into facial wrinkles to supplement the recipient’s own tissue, or using an acellular dermal product to reinforce a tendon and protect the soft tissue structure from mechanical stress. VIA Disc^® NP clearly, by these definitions and examples, functions to supplement inadequate nucleus pulposus tissue in a recipient, as it enhances the cushioning ability of the disc resulting in improved function and reduced pain, but it does not repair the underlying causes of the patient’s discogenic pain. That is precisely how the product is being marketed.

As such, VIA Disc^® NP is not an intervertebral disc repair product and thus cannot be appropriately included in an LCD that addresses coverage for intervertebral disc repair products. In the event it finalizes the LCD as to other products, the MAC should clearly note that VIA Disc^® NP and other products that are not for repair of the intervertebral disc are excluded from the scope of the LCD.

IV. The Proposed LCD and Draft Article are inconsistent in that the Proposed LCD proposes non-coverage for all intradiscal injection therapies, whereas the Draft Article identifies non-covered codes only for some of the services that the Proposed LCD would not cover.

In addition to concerns specific to VIA Disc^® NP discussed above, there are other reasons for the MAC not to advance or finalize the Proposed LCD and Draft Article. The Proposed LCD proposes a “non-coverage policy for all injections for Intervertebral Disc Repair” and goes on to discuss 8 product categories in addition to the 1 including VIA Disc^®. The Proposed LCD puts forward in its rationale for determination that there is “insufficient certainty of evidence of efficacy for any intradiscal injection therapy.” This would lead a reader to believe that the MAC intends to non-cover all intradiscal injection therapies, but you have not in fact reviewed the evidence for all individual intradiscal injection therapies.

Moreover, the Draft Article only, and without explanation, proposes non-coverage for CPT codes 0627T – 0630T, which apply solely to the percutaneous injection of allogeneic cellular and/or tissue-based products. This is untenably inconsistent with the Proposed LCD, as the Draft Article in practice permits ongoing coverage for some intradiscal injection therapies (i.e., any reported with CPT codes other than 0627T-0630T), whereas the Proposed LCD attempts to establish non-coverage for all of the types of products mentioned in the Proposed LCD. For example, the Proposed LCD would provide for non-coverage of intradiscal platelet rich plasma, which is furnished in a procedure reported with CPT code 0232T (injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed). Yet, CPT code 0232T is not included in the list of non-covered codes in the Draft Article.

Given the significant incongruity between the Proposed LCD and Draft Article, in addition to the reasons specific to VIA Disc^® NP stated above, the MAC should rescind both documents. You should not establish any coverage policy with respect to these injections without providing the public an opportunity to comment on a consistent and aligned Proposed LCD and Draft Article in which the MAC’s coverage position is clearly understandable.

V. Conclusion

At the end of this process, as to Vivex^®’s product VIA Disc^® NP, it should be clear that the product remains eligible for coverage in your jurisdictions. This should be grounded in either or both of the following facts: (i) the Proposed LCD process has not properly included or discussed the “particular item” VIA Disc^® NP, and/or (ii) that VIA Disc^® NP is not an intervertebral disc repair product and thus is outside the scope of an Intervertebral Disc Repair LCD. For this clarity to occur, the MAC must not mention VIA Disc^® NP in any finalized LCD and article, except to the extent it makes clear that VIA Disc^® NP remains available for coverage on a claim-by-claim basis. In the alternative, the MAC should rescind the current Proposed LCD and reassess its policy in light of what we have shared here, prior to releasing a new proposed LCD.

Taking these steps is critical to ensure ongoing patient access to VIA Disc^® NP, a technology which critically provides a non-opioid, non-surgical alternative to obtain relief from discogenic pain. Further, given the level of physician specialty society support for VIA Disc^® NP and the favorable developing evidence on the product, now is not the time to diminish patient access to the product. Rather, the MAC should endeavor to facilitate access to it in order to preserve a non-opioid, non-surgical, and less invasive option for patients that may negate the need for future interventions and will lead to lower costs for the Medicare program and lower out-of-pocket expenditures for patients.

Thank you for your time and attention to this matter. We look forward to continuing to work with you to ensure appropriate coverage for therapies such as VIA Disc^® NP and improve access by Medicare beneficiaries to important treatments for discogenic pain.

References were provided for review.

Thank you for your comments. We agree that there was only review of 1 study for Via Disc^® as this was the only peer reviewed published literature. At the time of publication, there were no peer reviewed published papers on Via Disc^® NP. The results of the 35-patient pilot study were not published at the time the LCD was written. To be included as evidence, the study must be published in a peer reviewed journal. The 29-patient pilot study was published 12/2/2024. The LCD will be updated to include review of this study.

Societal guidelines are considered and evaluated for potential bias while editorial letters, unpublished literature, and proceedings from annual meetings do not meet CMS criteria as evidence for review.

The statement “there were no statistically significant differences between Via Disc^® NP and placebo (saline) treatment groups” was a typo and has been amended to Via Disc^® without the use of NP.

The discussion of Via Disc^® was updated by adding a sentence stating that it is no longer available.

For a service to be considered “reasonable and necessary” under §1862(a)(1)(A) of the Social Security Act, it must be furnished in accordance with acceptable standard medical practice for the diagnosis or treatment of the condition. To meet this requirement, an acceptable standard must be established and supported by the medical literature. While the recently published pilot study shows promising early results, it is limited by the factors described above and does not provide sufficient evidence to meet the criteria for reasonable and necessary. In the absence of sufficient supporting evidence, this product is non-covered. Via Disc^® NP is regulated under FDA section 361 human cells, tissues and cellular and tissue-based products (HCT/P) as homologous use for nucleolus pulposus tissue the intervertebral disc. It is administered via intervertebral disc injection. The mechanism and route of action is not defined in the current literature or FDA clearance process. Therefore, the policy has been revised to clarify the intent as non-coverage of all agents injected into the intervertebral disc regardless of the proposed mechanism which includes repair, supplementation, homologous use, or other proposed actions. The decision for coverage vs non-coverage is based entirely on the evidence of effectiveness and improved patient outcomes.

We are aware that CPT codes 0627T – 0630T were developed to describe the percutaneous injection of allogeneic cellular and/or tissue-based products. However, the LCD addresses all products, regardless of whether the procedure is billed using 0627T-0630T, unspecified codes or other codes to represent intervertebral disc injections. CPT 0232T is not addressed in this LCD as it is addressed in the following LCDs: Platelet Rich Plasma L38745, Platelet Rich Plasma Injections for Non-Wound Injections L39023 and L39058 as non-covered. The other injectates included in review are billed under unspecified CPT 64999 and subject to case-by-case review by the MAC. Thus, there is no singling out of Via Disc^® NP in the billing and coding article.

The following comment was received from multiple stakeholders.

As an Interventional Pain Management Physician, I am committed to finding the most effective treatments possible for my patients. When it comes to addressing Discogenic Low Back Pain, VIA Disc^® NP can be an invaluable treatment.

For patients living with discogenic low back pain, VIA Disc^® NP is the only available option to address their degenerated discs directly. By offering this novel allograft in my practice, I can help people find renewed hope and offer a minimally invasive procedure to potentially avoid fusion surgery. In my career, I have seen many other disc options including discectomy for degenerative disc, but none has provided the low risk profile and efficacy of this product.

I would like to note the clinical study below demonstrating my patients’ safety benefits.

Beall DP, Wilson GL, Bishop R, Tally W. VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease. Int J Spine Surg. 2020;14(2):239-253. Published 2020 April 30. Doi:10.14444/7033. PMID:32355632

• Initial results from the 24-patient safety cohort suggested that VIA Disc may be implemented in a safe manner that improves disability and reduces pain over a 12-month period.

Lastly, ISASS has recognized VIA Disc^® NP as an effective solution to tackle discogenic low back pain, signifying its potential in the advancement of spinal surgeries.

Patients deserve the highest quality care, and so I strongly urge you to reconsider your decision by allowing me to provide VIA Disc^® NP in my practice, and to all patients. This is a much-needed treatment option that we should keep available for all patients to give a less expensive and more conservative option.

Thank you for your comments. The article cited was reviewed in the LCD. We have not received any published recommendations or guidelines from ISASS.

I am a potential patient of this procedure, I suffered lower back pain because of 2 degenerative disc that happened after an endoscopic discectomy. I was diagnosed with a herniated disc at level L4, L5 S1 as a result of an accident in 2017.

I was instructed to do this procedure not knowing the long-term effects of my Neucleus Pulposis being compromised because the annulus fibers were cut in that surgery. I now have a pfhirmman grade 7 on both disc and live with intense pain from 7-10 for the last 4 years.

One of the main problems is billing for CPT code 0627T & 0629T which is for the Allograft product of VIA DISC. I have been told these codes are not coming up in the CMS system but are available on the Medicare.gov site.

Everywhere I went the billing department would say nothing is coming up. It’s been this way for the past couple years. I’ve gone to several places only to realize the problem is the Codes not being in the CMS database for internal billing. Meanwhile my condition is getting worse by the day. I’m 55 years old that feels 80 because of my degenerated disc that I can’t seem to fix.

I’ve just recently been talking to people about a potential Lumbar disc replacement which I’m really nervous about because I hear they have to go through your stomach like a C-section to get to your lumbar spine. It scares me to think about; but I don’t have the money to pay for these intradiscal injections that I honestly feel would help without the invasive surgery.

Please help us by allowing these new treatments to be available and help save a person’s life from this excruciating back pain.

Images provided for review.

Thank you for your comments. There was no literature included with this comment.