CurrentColorado Rocky Mountain Health PlansPolicy 2026T0556FF

Subacromial Balloon Spacers for Rotator Cuff Tears (Coverage Criteria)

Governs coverage and evidence assessment for subacromial balloon spacers used to treat massive or irreparable rotator cuff tears for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySubacromial Balloon Spacers for Rotator Cuff Tears (Coverage Criteria)

Policy CodePolicy 2026T0556FF

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

Key ActionDocument MRI confirmation of a full-thickness massive rotator cuff tear, prior failed conservative therapy, and surgeon training when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 RCTRCTs included

~894Total shoulders

3.6%Device complication rate

5%Salvage RSA

≤2 yrsMax follow-up

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Coverage Determination and Rationale

Overall coverage determination

Covered when ALL of the following reflect the policy's overall determination:

Primary stance: Surgery of the shoulder is proven and medically necessary in certain circumstances per InterQual procedures; subacromial balloon spacers (SABS) for treatment of rotator cuff tears are unproven and not medically necessary due to insufficient evidence of efficacy.

Refer to InterQual CP: arthroscopy, joint replacement, and related shoulder procedure criteria for covered indications; SABS are excluded as not medically necessary.

Evidence synthesis and selection considerations

Evidence synthesis and guideline-based selection considerations informing the policy (summarized):

Evidence and guideline considerations: Randomized trial data (SPACE RCT) report comparable functional outcomes between InSpace and partial repair through 24 months with earlier recovery at 6 weeks, but results are limited by nonstandardized concomitant procedures and potential bias. Systematic reviews and evidence assessments (Hayes, ECRI) characterize the evidence base as small, heterogeneous, and of low quality with inconclusive comparative effectiveness beyond two years. NICE (2023) recommends not using biodegradable subacromial spacers when debridement is a suitable option and recommends use only in research when debridement is not suitable; it also advises multidisciplinary patient selection and surgeon training. The FDA granted DeNovo Class II clearance for the InSpace device with a labeled indication in selected patients aged ≥65 years for shorter surgical time compared to partial repair.

Reflects combined trial results, evidence reviews, regulatory status, and guideline recommendations; limitations in long-term and comparative data support the not medically necessary stance.

Use of subacromial balloon spacers (SABS), including the InSpace biodegradable subacromial spacer, is considered unproven and not medically necessary for the treatment of rotator cuff tears due to insufficient high-quality evidence of efficacy. The published literature is limited by short-term follow-up, small and heterogeneous studies, many nonrandomized or without control groups, and potential industry or developer sponsorship that may introduce bias. Refer to InterQual criteria for established covered shoulder procedures; SABS are excluded as not medically necessary.

Per NICE Interventional Procedures Guidance (2023), do not use biodegradable subacromial spacer insertion when debridement is a suitable option. When debridement is not suitable, NICE recommends use of the spacer only in the context of research with randomized trials, defined patient selection, and follow-up of at least 2 years.

Subacromial balloon spacers for rotator cuff tears are considered unproven and not medically necessary. Available studies are generally short-term, small, heterogeneous, and of low quality; many lack controls or randomization and have potential bias from nonblinded assessments and industry involvement. Because comparative therapeutic value versus accepted treatments (for example, debridement or partial repair) is unknown, current evidence does not support routine coverage.

Comparative evidence for subacromial balloon spacers is inconclusive and predominantly low quality. Systematic reviews and evidence assessments report limited participant numbers, inconsistent concomitant procedures, and no outcomes reported beyond two years in comparative studies; consequently, any potential clinical benefit should be viewed cautiously given the very poor quality of the available studies.

Procedure and Billing Codes

Applicable CPT Codes (reference)CPT

23470	Arthroplasty, glenohumeral joint; hemiarthroplasty.
23472	Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement).
23473	Revision of total shoulder arthroplasty; humeral or glenoid component.
23474	Revision of total shoulder arthroplasty; humeral and glenoid component.
29805	Arthroscopy, shoulder, diagnostic, with or without synovial biopsy (separate procedure).
29806	Arthroscopy, shoulder, surgical; capsulorrhaphy.
29807	Arthroscopy, shoulder, surgical; repair of slap lesion.
29819	Arthroscopy, shoulder, surgical; with removal of loose body or foreign body.
29820	Arthroscopy, shoulder, surgical; synovectomy, partial.
29821	Arthroscopy, shoulder, surgical; synovectomy, complete.

1–10 of 18

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Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and applicable CPT codes

See list of applicable CPT codes provided in the policy; inclusion is for reference and does not guarantee coverage. Prior authorization and documentation may be required per the member's benefit plan.

Referenced CPT codes include: 23470, 23472, 23473, 23474, 29805, 29806, 29807, 29819, 29820, 29821, 29822, 29823, 29824, 29825, 29826, 29827, 29828, and 29999.
Listing of a code does not imply the service is covered; benefit coverage is determined by the member-specific plan.

Prior Authorization

Prior authorization recommended for InSpace placement

Prior authorization is recommended to verify appropriate patient selection, documentation of failed conservative therapy, and surgeon training when InSpace is proposed; NICE also recommends use only in research when debridement is not suitable.

Prior auth should confirm failed conservative therapy and that patient selection matches device labeling/indications.
Confirm treating surgeon has specific training in inserting the device; consider multidisciplinary selection.

Device Description and Background

Subacromial balloon spacers (e.g., InSpace) are biodegradable balloon implants intended to act as a spacer to reduce friction between the acromion and humeral head in massive or irreparable rotator cuff tears. The device is designed to biodegrade over approximately 12 months and may be used alone or with debridement or partial repair; however, device labeling and approvals are limited and selection should follow established clinical guidance and multidisciplinary assessment.

Definitions and Key Terms

Massive, irreparable rotator cuff tear (MIRCT)

DefinitionFull-thickness rotator cuff tear often involving ≥2 tendons or measuring ≥5 cm with limited reparability and persistent symptoms despite conservative therapy (used to describe massive, irreparable rotator cuff tears in clinical trials).

Imaging requirementMRI confirmation of a full-thickness tear measuring ≥5 cm and involving ≥2 tendons (as specified in RCT inclusion criteria).

Clinical contextTypically persistent symptoms after ≥4 months of failed conservative therapy and preserved deltoid function with passive range of motion, per trial criteria.

Reparability implicationCharacterized by limited reparability — often considered inoperable or not amenable to complete rotator cuff repair.

Massive rotator cuff tear (MRCT)

Definition

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicySubacromial Balloon Spacers for Rotator Cuff Tears (Coverage Criteria)

Policy CodePolicy 2026T0556FF

Change TypeNo material change

Effective DateJan 1, 2026

Next Review Date

Key ActionDocument MRI confirmation of a full-thickness massive rotator cuff tear, prior failed conservative therapy, and surgeon training when requesting prior authorization.

SourceLink

On This Page

Step Therapy

Reference to step criteria

Refer to established InterQual shoulder surgery criteria for determination of medically necessary shoulder surgeries; the policy identifies SABS as unproven and not medically necessary.

Use InterQual CP: Arthroscopy or Arthroscopically Assisted Surgery, Shoulder and related modules for coverage decisions.
SABS are classified in this policy as unproven and not medically necessary.

Step Therapy

Debridement preferred before spacer

When debridement is a suitable option, debridement should be considered before biodegradable spacer insertion per NICE guidance; this preference may affect coverage determinations.

NICE states: 'When debridement is a suitable option, biodegradable subacromial spacer insertion for rotator cuff tears should not be used.'

Documentation Required

Medical record and coding note

Medical records may be requested to assess whether the member meets clinical criteria; inclusion of codes is for reference only and does not guarantee coverage or payment.

Benefit coverage is determined by the member-specific benefit plan and applicable laws.
Medical records documentation used for reviews does not guarantee coverage of the service requested.

Documentation Required