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Medical Policy Balloon Spacers for Treatment of Irreparable Rotator Cuffs of the Shoulder Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 176 BCBSA Reference Number: 7.01.180 (For Plan internal use only) NCD/LCD: N/A Related Policies
None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Subacromial balloon spacer implantation is considered INVESTIGATIONAL as a treatment for massive, irreparable, full-thickness rotator cuff tears.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

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Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. The following codes are included below for informational purposes only; this is not an all-inclusive list.

The following HCPCS code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

HCPCS Codes HCPCS codes:

Code Description C9781 Arthroscopy, shoulder, surgical; with implantation of subacromial spacer (e.g., balloon), includes debridement (e.g., limited or extensive), subacromial decompression, acromioplasty, and biceps tenodesis when performed

Description Massive, Irreparable Full-Thickness Rotator Cuff Tears Rotator cuff tears represent a common shoulder injury affecting a significant portion of the population, with overall incidence rates ranging from 5% to 40%, and approximately 54% of individuals over the age of 60 experiencing partial or complete tears.1, Massive tears, commonly defined as full-thickness tears involving at least 2 tendons or measuring > 5 cm in the coronal plane, constitute about 20% of all rotator cuff tears and 80% of recurrent tears. However, multiple definitions exist for what constitutes a massive tear, and a recent Delphi consensus of expert orthopedic shoulder specialists suggested that the most agreed upon definition would be tears with retraction of tendons to the glenoid rim in either the coronal or axial plane and/or a tear with ≥ 67% of the greater tuberosity exposed in the sagittal plane.2,3, Rotator cuff tears are considered irreparable when they cannot be restored to their original insertion on the tuberosities using standard surgical release and mobilization techniques due to excessive size, tendon retraction, and muscle degeneration, including atrophy and fatty infiltration.3, Without intervention, the natural progression of untreated massive tears can lead to muscle atrophy, fatty infiltration, and further tendon retraction, rendering potentially reparable tears irreparable over time.

Treatment Management of massive, irreparable full-thickness rotator cuff tears (MIRCTs) encompasses both nonoperative and surgical approaches. Nonoperative treatments primarily focus on alleviating pain and enhancing shoulder function. These include physical therapy, activity modification to reduce strain on the shoulder, and pharmacological interventions such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections to manage inflammation and discomfort.4, Surgical interventions are considered when nonoperative treatments fail to provide adequate relief or in patients with higher functional requirements. Options include partial rotator cuff repair, which may restore some function depending on the tear's extent and tissue quality.3, For patients with significant deficits, tendon transfer procedures, such as latissimus dorsi or lower trapezius transfers, can compensate for lost rotator cuff function. Additionally, reverse total shoulder arthroplasty is a treatment option, particularly in individuals with pseudoparalytic shoulder, irreparable rotator cuff tears, and glenohumeral osteoarthritis who are not candidates for tendon transfers.3,. Arthroscopic debridement with subacromial balloon spacer implantation (SBSI) is being investigated as a potential alternative treatment for managing MIRCTs.

Summary
Description Subacromial balloon spacer implantation represents a minimally invasive treatment modality for massive irreparable rotator cuff tears. The biodegradable spacer is introduced arthroscopically into the subacromial region where it functions to depress the humeral head, successfully reestablishing normal shoulder mechanics by blocking upward displacement of the humeral head toward the acromion. This technique addresses pain and functional limitations by creating a temporary articulating interface between the humeral head and acromion by reducing subacromial impingement. The biodegradable spacer

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gradually deflates over several months, potentially allowing time for adaptation of surrounding tissues and pain reduction without the complexity of tendon transfers or reverse shoulder arthroplasty.

Summary of Evidence For individuals with massive irreparable rotator cuff tears (MIRCTs) who receive subacromial balloon spacer implantation (SBSI) as an adjunct to routine care, including surgery, the evidence includes meta- analyses, RCTs, non-randomized comparative studies, and uncontrolled studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Two RCTs provided conflicting evidence regarding the efficacy of SBSI. The non-inferiority trial comparing SBSI to partial repair found comparable improvements in American Shoulder and Elbow Surgeons (ASES) scores at 24 months, with SBSI demonstrating better forward elevation and shorter operative times. However, an FDA analysis recommended using a composite primary efficacy endpoint instead of ASES alone and found non- inferiority only in the subset of patients aged 65 years or older. Another RCT that compared arthroscopic debridement with and without SBSI was terminated early due to futility, with results favoring debridement alone over SBSI. This was supported by a 2024 meta-analysis comparing SBSI to arthroscopic debridement, which found that debridement alone demonstrated superior outcomes in pain reduction and Constant-Murley scores. A second review showed significant improvements in pooled patient-reported outcomes following SBSI from baseline through 2 years follow-up on Constant-Murley, ASES scores, and pain reduction, but a meta-analysis of comparative trials revealed no benefits over alternative therapies. Nonrandomized comparative studies typically reported improvements in functional outcomes and pain scores following SBSI compared to baseline; however, none showed it to be superior to other surgical reconstruction techniques. Case series have reported long-term follow-up of up to 8 years, with most showing a sustained benefit in functional and pain outcomes. Device-related complications were uncommon, with one review reporting that most studies (52%) did not observe any complications related to SBSI. Complications reported included implant migration, implant removal due to pain, early deflation of the implant resulting in temporary functional impairment, worsening of glenohumeral osteoarthritis, revision to other surgical procedures, and infection. Multiple studies emphasized the importance of proper patient selection and noted that while SBSI may provide short-term benefits, its long-term effectiveness compared to alternative treatments remains uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 5/2026 Policy updated with literature review through February 25, 2026; no references added. Policy statements unchanged. 9/2025 New medical policy describing investigational indications. Subacromial balloon spacer implantation is considered investigational as a treatment for massive, irreparable, full- thickness rotator cuff tears. Effective 9/1/2025. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

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2. Schumaier A, Kovacevic D, Schmidt C, et al. Defining massive rotator cuff tears: a Delphi consensus study. J Shoulder Elbow Surg. Apr 2020; 29(4): 674-680. PMID 32197762
3. Novi M, Kumar A, Paladini P, et al. Irreparable rotator cuff tears: challenges and solutions. Orthop Res Rev. 2018; 10: 93-103. PMID 30774464

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23. Familiari F, Nayar SK, Russo R, et al. Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears Is Associated With Improved Shoulder Function and High Patient Satisfaction. Arthroscopy. Feb 2021; 37(2): 480-486. PMID 33068742
24. Garofalo R, De Crescenzo A, Fontanarosa A, et al. Rotator cuff repair protected with subacromial balloon spacer shows a low rate of non-healing. Knee Surg Sports Traumatol Arthrosc. Jun 2022; 30(6): 2123-2129. PMID 35022825
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