CurrentBlue Cross Blue Shield - MassachusettsPolicy 838

Intradiscal Injection of Allograft (Viable Nucleus Pulposus / Allogeneic Cell Therapy)

This policy governs coverage for percutaneous intradiscal injection of allogeneic cellular and/or tissue-based products for degenerative disc disease for Blue Cross Blue Shield of Massachusetts members across commercial and Medicare product lines.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyIntradiscal Injection of Allograft (Viable Nucleus Pulposus / Allogeneic Cell Therapy)

Policy CodePolicy 838

Change TypeClarified — literature updatesno change to policy stance

Effective Date

Next Review Date

Key ActionObtain precertification/preauthorization for inpatient procedures; outpatient intradiscal allograft injections are not covered and may be denied.

SourceLink

POLICY UPDATE CHANGES

Policy updated with literature review through March 12, 2026; references added. Policy statement unchanged.

Policy updated with literature review through April 7, 2025; references added. Policy statement unchanged.

Investigationalcoverage stance

Not coveredoutpatient coverage

0627T-0630Tinvestigational CPTs

Preauth requiredinpatient authorization

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Coverage Determinations

Investigational — Not Covered / Not Established

Covered when ALL of the following are met:

Overall stance: Injection of allograft into the intervertebral disc for the treatment of degenerative disc disease is considered INVESTIGATIONAL.

Policy applies to Commercial and Medicare product lines; outpatient services are not covered for specified product lines.

Outpatient coverage: Outpatient percutaneous intradiscal injection of allogeneic cellular and/or tissue-based products is not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue members.

Claims for outpatient services may be denied.

Evidence summary: The evidence is insufficient to determine that intradiscal viable allograft injections improve net health outcomes; 12-month RCT results did not show consistent statistically significant benefit on co-primary pain and disability endpoints, and additional well-conducted trials with complete follow-up are needed.

Procedure considered investigational and not medically necessary.

Injection of allograft into the intervertebral disc for the treatment of degenerative disc disease is considered INVESTIGATIONAL for Commercial Members (Managed Care HMO and POS, PPO, and Indemnity) and Medicare Members (Medicare HMO Blue SM and Medicare PPO Blue SM).

Outpatient percutaneous intradiscal injection of allogeneic cell/tissue products is not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM members.

The summary of evidence includes 12-month results from a randomized controlled trial comparing active allograft injection, placebo allograft, and conservative management. The trial did not find statistically significant differences on the co-primary pain and disability endpoints through the first 12 months of follow-up.

Although some secondary responder analyses favored the active allograft on certain pain and disability outcomes, limitations in comparators, outcome relevance, data completeness, and statistical power prevent definitive conclusions. Therefore, the evidence is insufficient to determine that intradiscal viable allograft injections improve net health outcomes, and the procedure is considered investigational.

Coding

Investigational CPT CodesCPTNot Covered

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).

Provider Actions and Requirements

Denial Risk

Investigational procedure codes

The following CPT codes (0627T–0630T) for percutaneous intradiscal injection of allogeneic cellular/tissue products are considered investigational and may be denied as not medically necessary.

0627T, 0628T, 0629T, 0630T

Prior Authorization

Precertification required (inpatient)

Precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. Failure to obtain required inpatient authorization may result in denial of payment.

Documentation Required

Background

Degenerative disc disease involves age-related biochemical and structural changes in the intervertebral disc that can contribute to chronic back pain and radiculopathy. Most back pain is self-limited and initial management is conservative, including analgesics, exercise, and multidisciplinary rehabilitation.

Cellular and tissue-based intradiscal therapies are intended to restore disc structure and function (for example, by rehydration, height restoration, or repopulation of nucleus pulposus cells), but high-quality trial data demonstrating consistent, clinically meaningful improvements in symptoms or function compared with conservative care are lacking at this time.

Definitions

Viable nucleus pulposus allograft / allogeneic cellular product — definition and intended use

TermViable nucleus pulposus allograft / allogeneic cellular product

DefinitionAn intradiscal injectable product composed of nucleus pulposus tissue and viable cells intended to supplement or repopulate degenerated intervertebral disc tissue.

Intended useDelivered via percutaneous intradiscal injection into a degenerated disc to restore or repopulate nucleus pulposus tissue (studied as a cellular therapy for disc degeneration).

Delivery methodPercutaneous intradiscal injection (typically under image guidance) of a mixture of nucleus pulposus allograft and viable cells.

Degenerative disc disease — definition describing biochemical and morphologic changes

Term