ModifiedUnitedHealthcarePolicy CS109TN.W

Surgery of the Shoulder (Tennessee Medicaid/CoverKids)

This policy governs medical necessity and coding guidance for shoulder surgical procedures for Tennessee Medicaid and CoverKids, and states the payer stance on subacromial balloon spacers for massive irreparable rotator cuff tears.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Shoulder (Tennessee Medicaid/CoverKids)

Policy CodePolicy CS109TN.W

Change TypeRevised clinical coverage languageevidence and references updated

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit prior authorization documentation showing the procedure meets InterQual clinical coverage criteria and document patient selection when considering subacromial balloon spacers.

SourceLink

POLICY UPDATE CHANGES

Revised language pertaining to medical necessity clinical coverage criteria and references to InterQual content.

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

Tennessee Medicaid/CoverKidsProgram scope

Not medically necessarySABS stance

InterQualClinical criteria source

1–2 yrsMax follow-up

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Coverage Criteria

InterQual-based medical necessity

Covered when InterQual criteria are met

InterQual-based coverage: Shoulder surgical procedures (arthroscopy, diagnostic arthroscopy, joint replacement, removal/revision) are considered proven and medically necessary when they meet the corresponding InterQual clinical coverage criteria.

Providers must refer to the InterQual CP lists cited in the policy for specific clinical indicators and required documentation.

SABS - Unproven / Not Medically Necessary

Not covered / Not medically necessary

Subacromial balloon spacers (SABS): Subacromial balloon spacers (including InSpace) for treatment of rotator cuff tears are considered unproven and not medically necessary due to insufficient evidence of efficacy, short follow-up, small and heterogeneous studies, and inconclusive comparative data.

NICE recommends against use when debridement is suitable and restricts use to research when debridement is not suitable.

Clinical coverage considerations

Coverage consideration informed by evidence and external guidance

Device indication and patient selection: Patient has a massive, irreparable full-thickness rotator cuff tear and, when considered, selection aligns with the FDA DeNovo indication (InSpace: typically ≥65 years with mild to moderate glenohumeral osteoarthritis) or the patient is enrolled in appropriate research per NICE guidance when debridement is not suitable.age >=65 per FDA for labeled indication

Comparative effectiveness versus debridement or partial repair is inconclusive; long-term outcomes beyond 2 years are lacking.

Use context: Use as a standalone treatment or adjunct to partial repair is not established; consider only in the context of randomized research or with documented multidisciplinary selection and surgeon training.follow-up planned for at least 2 years per NICE guidance

NICE recommends RCTs with detailed patient selection and ≥2 years follow-up; ECRI and other reviews call for larger, high-quality trials.

This policy explicitly excludes routine coverage or support for subacromial balloon spacers (SABS) for rotator cuff tears outside of defined research contexts. The policy states that SABS are considered unproven and not medically necessary due to insufficient evidence of efficacy and limited, low-quality comparative data. External guidance (NICE IPG 775) restricts use to research when debridement is not suitable and otherwise advises against their use when debridement is a suitable option.

NICE Interventional Procedures Guidance (IPG 775, 2023) recommends that when debridement is a suitable option for a rotator cuff tear, biodegradable subacromial spacer insertion should not be used. When debridement is not suitable, NICE advises that spacer insertion should be confined to research settings with randomized trials preferred and specified requirements for patient selection, outcome measures, and follow-up of at least 2 years.

Based on the current evidence base, subacromial balloon spacers (including the InSpace system) are designated unproven and not medically necessary for treatment of rotator cuff tears. The literature is limited by short follow-up (none longer than two years in key reviews), small or nonrandomized studies, heterogenous designs, and potential industry bias; comparative effectiveness versus debridement or partial repair is inconclusive. As a result, routine coverage is not supported.

The policy notes that using subacromial balloon spacers as a routine alternative to arthroscopic debridement or partial repair is not supported by current comparative evidence and lacks long-term outcomes. Systematic reviews and updates (ECRI, Hayes) report inconclusive comparative effectiveness and call for larger randomized trials with longer follow-up; NICE similarly limits use to research when debridement is unsuitable. Therefore SABS should not be considered a routine substitute for established surgical options.

Coding and Regulatory References

Reference shoulder arthroplasty CPT codesCPT

23470	Arthroplasty, glenohumeral joint; hemiarthroplasty.
23472	Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (e.g., total shoulder)).
23473	Revision of total shoulder arthroplasty, including allograft when performed; humeral or glenoid component

Reference shoulder arthroscopy and related CPT codesCPT

23474	Revision of total shoulder arthroplasty, including allograft when performed; 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.
29822	Arthroscopy, shoulder, surgical; debridement, limited, 1 or 2 discrete structures (e.g., humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies]).
29823	Arthroscopy, shoulder, surgical; debridement, extensive, 3 or more discrete structures (e.g., humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies]).
29824	Arthroscopy, shoulder, surgical; distal claviculectomy including distal articular surface (Mumford procedure).

1–10 of 15

1/2

Regulatory referencemixed

FDA De Novo DEN200039

DeNovo classification documentation for InSpace Subacromial Tissue Spacer System

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization for shoulder surgical procedures must reference InterQual clinical coverage criteria that are applicable to the procedure (see InterQual CP: Procedures for Arthroscopy or Arthroscopically Assisted Surgery, Shoulder; Diagnostic Arthroscopy, Shoulder; Joint Replacement, Shoulder; and Removal and Replacement or Revision, Joint Replacement, Shoulder). Requests for subacromial balloon spacers (SABS) must reflect the device indication and be evaluated against InterQual-referenced criteria and any applicable FDA device indications (e.g., the InSpace DeNovo indication).

Prior authorization must identify the specific device and clinical indication.
Include the relevant InterQual procedure criteria name(s) used to justify medical necessity.
If asserting device-specific indications, document how patient meets the FDA DeNovo indication when relied upon (e.g., age ≥65 and other device-specified criteria).

Documentation Required

InterQual Documentation Requirement

Background

Massive irreparable rotator cuff tears (MIRCTs) may be managed with a range of surgical approaches depending on patient factors and tear characteristics. Options include arthroscopic debridement (with or without limited repair), partial rotator cuff repair, tendon transfer procedures, superior capsular reconstruction, and in selected older patients, reverse total shoulder arthroplasty. Biodegradable subacromial balloon spacers (InSpace) are investigational/novel devices intended to act as a temporary spacer to reduce subacromial friction and improve shoulder mechanics; they biodegrade over about 12 months. Current evidence for SABS shows short-term improvements in some studies but is limited by small sample sizes, heterogenous designs, potential conflicts of interest, and lack of long-term comparative data, so their role remains investigational and restricted by guidance to research settings when debridement is not suitable.

Definitions

inv-20: InSpace (biodegradable subacromial spacer) — definition

Device nameInSpace (biodegradable subacromial spacer)

Manufacturer / trade nameInSpace™ Subacromial Tissue Spacer System (Stryker / Ortho‑Space Ltd.)

Device descriptionMinimally invasive, biodegradable balloon spacer placed in the subacromial space to reduce friction between acromion and humeral head; designed to biodegrade over ~12 months

Intended use (general)Used as a spacer to restore shoulder function and reduce pain in massive, inoperable rotator cuff tears (MIRCTs)

Key device featuresDoes not require anchors or a permanent implant; intended to preserve musculoskeletal and bone tissues

inv-21: InSpace Subacromial Tissue Spacer System — FDA De Novo and indication

Revision History

2025-11-01RevisionLatest

Revised Coverage Rationale language related to medical necessity clinical coverage criteria: added a reference to InterQual CP: Procedures, Removal and Replacement or Revision, Joint Replacement, Shoulder; removed older InterQual references for arthrotomy and certain TJR revision items; updated Clinical Evidence and References sections.

2024-07Evidence update

ECRI Institute clinical evidence assessment for InSpace updated (ECRI update cited July 2024) noting inconclusive comparative evidence and limited long-term outcomes.