ModifiedUnitedHealthcarePolicy CS1O9TN.V

Surgery of the Shoulder — Subacromial Balloon Spacers (SABS)

This Tennessee Medicaid/CoverKids medical policy addresses surgical procedures of the shoulder, with specific coverage rationale and evidence review regarding subacromial balloon spacers for massive/irreparable rotator cuff tears, and applies to providers and members covered under Tennessee Medicaid/CoverKids.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Shoulder — Subacromial Balloon Spacers (SABS)

Policy CodePolicy CS1O9TN.V

Change TypeSupporting information updated

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionDo not authorize subacromial balloon spacers for rotator cuff tears — they are considered unproven and not medically necessary.

SourceLink

POLICY UPDATE CHANGES

Supporting Information Updated Clinical Evidence and References sections to reflect the most current information

~894total shoulders in reviews

3-5%complication/conversion rate

2 yrsmax follow-up reported

Tennesseeapplicability

2025-01-01policy revision

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Rationale and Determinations

Not Medically Necessary — Subacromial Balloon Spacers

Covered when ALL of the following are met:

Primary coverage stance: Subacromial balloon spacers for the treatment of rotator cuff tears are unproven and not medically necessary due to insufficient evidence of efficacy.

Statement from policy coverage rationale; see supporting evidence summaries.

Use of subacromial balloon spacers for the treatment of rotator cuff tears is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Information about FDA actions is provided for reference only; FDA approval alone is not a basis for coverage. Surgeries are procedures and not regulated by the FDA, although devices used during surgery may require FDA review.

Procedure and Study Coding Notes

Applicable Procedure CPT Codes (referenced)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.
29806	Arthroscopy, shoulder; surgical; capsulorrhaphy.
29807	Arthroscopy, shoulder; repair of SLAP lesion.
29819	Arthroscopy, shoulder; removal of loose body or foreign body.
29820	Arthroscopy, shoulder; synovectomy, partial.
29821	Arthroscopy, shoulder; synovectomy, complete.

1–10 of 18

1/2

Study inclusion tear size — RCT criteria

Study inclusion tear sizeFull-thickness rotator cuff tear measuring ≥ 5 cm and involving ≥ 2 tendons (per cited RCT inclusion criteria)

Additional study inclusion requirementsAge ≥ 40 years, MRI confirming tear within 9 months of enrollment, functional deltoid and preserved passive ROM

Prior treatment requirementFailed conservative therapy for at least 4 months before enrollment in the RCT

Symptom severity thresholdVisual Analog Scale (VAS) score > 30 mm required for inclusion in the RCT

Provider Responsibilities, Prior Authorization & Billing Guidance

Note

Tennessee Medicaid / CoverKids Applicability

This Medical Policy applies to Tennessee Medicaid and CoverKids. Providers should follow state Medicaid and CoverKids prior authorization and billing processes and any Tennessee-specific requirements when submitting requests.

Policy Number: CS1O9TN.V
Effective Date: 2025-01-01

Prior Authorization

Plan-specific coverage verification

Use this UnitedHealthcare policy to interpret standard benefit plans. Always verify plan-specific coverage with the member’s benefit documents and check for any federal, state, or contractual requirements that may modify coverage. In the event of conflict, federal, state, or contractual requirements govern.

Reference the member’s specific plan benefits before rendering services
If state or contractual terms override this policy, follow those terms

Device Background and Clinical Context

Subacromial balloon spacers (also called the InSpace Subacromial Tissue Spacer System) are biodegradable implants that are placed in the subacromial space to act as a spacer between the acromion and humeral head. They are intended to reduce friction and improve shoulder function in patients with massive, irreparable rotator cuff tears and are designed to biodegrade over time (approximately 12 months in published descriptions).

Key Definitions and Terms

Subacromial Balloon Spacer (SABS) — device description

Device nameInSpace Subacromial Tissue Spacer System (Stryker)

Device typeMinimally invasive, biodegradable subacromial balloon spacer placed in the subacromial space

Intended purposeUsed as a spacer to eliminate friction between the acromion and humeral head to restore shoulder function and reduce pain in massive, inoperable rotator cuff tears

Biodegradation timeframeDesigned to biodegrade over approximately 12 months (manufacturer statement)

Massive Irreparable Rotator Cuff Tear (MIRCT) — study definition

Definition (study-used)Full-thickness massive rotator cuff tear measuring ≥ 5 cm and involving ≥ 2 tendons

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Shoulder — Subacromial Balloon Spacers (SABS)

Policy CodePolicy CS1O9TN.V

Change TypeSupporting information updated

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionDo not authorize subacromial balloon spacers for rotator cuff tears — they are considered unproven and not medically necessary.

SourceLink

On This Page

Note

FDA approval informational only

Coverage determinations must not be based solely on FDA approval. FDA status of a device or procedure is informational only; UnitedHealthcare may consider clinical evidence and plan terms when making coverage decisions.

FDA approval or De Novo classification does not guarantee coverage

Documentation Required

Coding and documentation note

Listing of procedure or diagnosis codes in this policy is for reference only and does not guarantee coverage or payment. Providers must verify member benefits and submit appropriate documentation to support medical necessity. Inclusion of a code is not a promise of reimbursement.

Verify benefits and eligibility prior to service
Document clinical rationale and supporting records with any authorization request

Note

Reference federal, state, and contractual requirements

When deciding coverage, always reference applicable federal, state, or contractual requirements for the member’s plan; those terms may supersede this Medical Policy. This policy is informational and does not override governing laws or contractual provisions.

In event of conflict, federal/state/contractual requirements govern
Check member’s specific plan documents before approving services

Note

Guidance on treatment sequencing

Clinical guidance (NICE) suggests that when debridement is a suitable option, biodegradable subacromial spacer insertion should not be used. When debridement is not suitable, spacer insertion should be limited to research settings with multidisciplinary patient selection and surgeons specifically trained in the procedure.

Debridement preferred when suitable
Spacer insertion only in research when debridement is not suitable; requires multidisciplinary selection and trained surgeons

Step Therapy

Step therapy requirements

No step therapy requirements are specified in this policy. Providers should still verify whether any applicable plan, state, or contractual requirements impose step therapy or other utilization management controls.

This policy does not establish step therapy protocols
Check the member’s plan for any utilization management rules

Denial Risk

Not medically necessary designation (denial risk)

Subacromial balloon spacers (SABS) for rotator cuff tears are considered not medically necessary due to insufficient evidence. Providers should be aware that claims may be denied if medical necessity is not supported.

SABS designated Not Medically Necessary – insufficient evidence
Providers should provide documentation if disputing a denial

Functional requirementsPreserved/functional deltoid muscle and preserved passive range of motion (per RCT criteria)

Clinical contextOften described as massive irreparable rotator cuff tear (MIRCT) in trials assessing SABS

InSpace subacromial spacer — device identifiers / names

Primary identifierInSpace Subacromial Tissue Spacer System

Common synonymInSpace subacromial spacer (subacromial balloon)

ManufacturerStryker (manufacturer-reported device)

Regulatory noteFDA De Novo classification granted for InSpace (informational only; FDA approval not a basis for coverage)