ModifiedUnitedHealthcarePolicy 2025T0556EE

Surgery of the Shoulder

Defines UnitedHealthcare's coverage stance and clinical context for shoulder surgery procedures, including arthroscopy and joint replacement, and states that subacromial balloon spacers for rotator cuff tears are unproven and not medically necessary. Applies to UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Shoulder

Policy CodePolicy 2025T0556EE

Change TypeRevised clinical criteria and supporting evidence

Effective DateSep 1, 2025

Next Review Date

Key ActionWhen requesting prior authorization, document that the patient meets InterQual procedure criteria and include evidence of device indications and consideration of alternative treatments such as debridement.

SourceLink

POLICY UPDATE CHANGES

Revised language pertaining to medical necessity clinical coverage criteria and updated supporting clinical evidence and references.

Not medically necessaryCoverage stance for SABS

12 codesProcedure codes included

Multiple reviews (2023–2025)Evidence summaries

3.6%Device complication rate

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Coverage and Medical Necessity Criteria

InterQual-based Medical Necessity

Covered when InterQual criteria for the referenced shoulder procedures are met.

InterQual-referenced coverage: Coverage for arthroscopy, arthroscopically assisted surgery (shoulder and adolescent), diagnostic arthroscopy +/- synovial biopsy, joint replacement, and revision of joint replacement is determined by meeting the relevant InterQual CP criteria referenced in the policy.

See InterQual CP procedures listed in the policy.

Subacromial Balloon Spacers (SABS) — Not Medically Necessary

Not medically necessary

SABS not medically necessary: Subacromial balloon spacers for treatment of rotator cuff tears (including the InSpace biodegradable spacer) are unproven and not medically necessary due to insufficient evidence of efficacy, short-term follow-up, small nonrandomized studies, heterogeneity, and potential industry or developer bias.

Refer to cited evidence reviews and summaries (Hayes, ECRI, Berk, Kunze, Verma, others).

Evidence and guideline-based considerations

Summary of evidence and guidance relevant to medical necessity considerations for SABS:

Evidence of short- to mid-term improvement: Systematic reviews and RCTs report short- to mid-term improvements in pain and function after SABS implantation (e.g., Berk et al. pooled improvements in Constant, ASES, Oxford, VAS; Kunze et al. reported high pooled rates of MCID achievement)

Quality of evidence is variable; many studies have limitations including heterogeneity, use of concomitant procedures, small sample sizes, and short follow-up.

Comparative effectiveness and long-term evidence: Comparative evidence versus debridement or partial repair is inconclusive; trials and reviews note follow-up generally ≤2–3 years and insufficient data on long-term outcomes, comparative effectiveness, and impact on subsequent salvage procedures (e.g., rate of salvage reverse arthroplasty ~5% in Berk et al.)

ECRI and Hayes assessments conclude comparative evidence is inconclusive and of low quality.

Regulatory and guideline constraints: Regulatory clearance and guidance impose restrictions: FDA DeNovo clearance (InSpace) specifies use in patients ≥65 years with massive irreparable full-thickness tears under defined conditions; NICE recommends not using biodegradable spacers when debridement is suitable and restricting use to research when debridement is not suitable, with multidisciplinary selection and surgeon training requirements.

Use of subacromial balloon spacers for the treatment of rotator cuff tears (including biodegradable devices such as InSpace) is considered unproven and not medically necessary due to insufficient evidence of efficacy. The available literature is limited by short follow-up, small nonrandomized studies, heterogeneity in study design, and potential industry or developer bias, and therefore does not establish clear, durable benefit compared with standard surgical options.

The National Institute for Health and Care Excellence (NICE) 2023 guidance recommends that when debridement is a suitable option, biodegradable subacromial spacer insertion should not be used. NICE further advises that if debridement is not suitable, spacer insertion should be used only in research, with randomized trials reporting patient selection, function, pain, quality-of-life, and at least 2 years of follow-up; selection and the procedure should involve a multidisciplinary team and surgeons with specific device training.

Subacromial balloon spacers (SABS), including the InSpace biodegradable spacer, are regarded as not medically necessary for routine treatment of massive irreparable rotator cuff tears because existing studies do not provide sufficient, high-quality evidence of comparative effectiveness. Systematic reviews and assessments note limitations such as small sample sizes, short follow-up (≤2 years), nonrandomized designs, heterogeneous concomitant procedures, and potential bias; these factors prevent firm conclusions that SABS improve long-term outcomes or are superior to debridement, partial repair, or other standard surgical options.

Evolving evidence reviews and independent assessments (Hayes evolving evidence reviews and ECRI clinical evidence assessment) report only minimal to low levels of support for the InSpace spacer and conclude that comparative effectiveness versus arthroscopic debridement or partial repair is inconclusive. Reviewers emphasize the need for larger randomized trials with longer follow-up to address uncertainties about durability of benefit, comparative outcomes, and impact on subsequent salvage procedures.

Applicable Procedure and Billing Codes

Applicable Procedure 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.
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.

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Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization: Device-Specific Considerations

Prior authorization is required for device-based procedures when the device indication, patient selection, and practitioner qualifications meet evidence-based criteria. For biodegradable subacromial spacers and other implantable shoulder devices, prior authorization requests must document that the member meets device-specific indications (for example: massive, irreparable, full-thickness rotator cuff tear as defined by imaging and surgical assessment) and any age or comorbidity limits noted by regulatory or manufacturer labeling.

Applicable codes: see policy Applicable Codes section (e.g., 23470, 23472–23474, 29805–29823)
If device indication is limited by age, comorbidity, or prior surgical history (per FDA or manufacturer labeling), include documentation demonstrating the member meets those limits
When the device is indicated only after other treatment options are unsuitable, include documentation of prior conservative therapies and reason(s) they were unsuitable

Note

Evidence-Based Selection and Procedure Appropriateness

Use evidence-based selection when considering biodegradable subacromial spacers or other novel shoulder implants. Follow the NICE recommendations: prefer debridement when it is a suitable option; reserve spacer insertion for cases where debridement is not suitable and, if used, consider only in the context of research. Document multidisciplinary case review and that the patient selection matches the populations studied (including tear size, function, pain, and quality-of-life measures).

Clinical Background and Context

Massive irreparable rotator cuff tears (MIRCTs) are large, inoperable full-thickness rotator cuff injuries that can cause pain, loss of function, and reduced quality of life. Surgical management options include debridement, partial rotator cuff repair, tendon transfers, superior capsular reconstruction, and reverse total shoulder arthroplasty. Investigational or adjunctive devices such as biodegradable subacromial balloon spacers (e.g., InSpace) have been developed to reduce friction between the acromion and humeral head and may provide short-term improvements in pain and function, but the evidence is limited by short follow-up, heterogeneity, and potential bias; therefore these devices remain of uncertain long-term benefit compared with established surgical treatments.

Device and Condition Definitions

InSpace Subacromial Tissue Spacer System — device description

Device nameInSpace Subacromial Tissue Spacer System (Stryker)

Device typeMinimally invasive biodegradable subacromial balloon spacer

Mechanism/purposePlaced in the subacromial space to eliminate friction between the acromion and humeral head, restore shoulder function, and reduce pain for MIRCTs

Design featuresPreserves musculoskeletal and bone tissues, does not require anchors or a permanent implant, biodegrades over ~12 months

Typical use settingUsed as a spacer (alone or with debridement or as adjunct to partial repair) for massive, inoperable/irreparable rotator cuff tears

MIRCTs — definition