Total Shoulder Arthroplasty

LCD Information Document Information Source LCD ID N/A LCD ID L39956 Original ICD-9 LCD ID Not Applicable LCD Title Total Shoulder Arthroplasty Proposed LCD in Comment Period N/A Source Proposed LCD DL39956 Opens in a new window Original Effective Date For services performed on or after 03/27/2025 Revision Effective Date For services performed on or after 03/27/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 12/12/2024 Notice Period End Date 03/26/2025 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 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Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD No changes between Proposed LCD and Final LCD. CMS National Coverage Policy Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, §1862(a)(1)(D) indicates no payment may be made in the case of clinical care where items and services provided are in research and experimentation. CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, §13.5.3 Evidentiary Content and §13.5.4 Reasonable and Necessary Provisions in LCDs Coverage Indications, Limitations, and/or Medical Necessity Indications of Coverage Total shoulder arthroplasty (TSA) is reasonable and necessary for each of the following conditions: Degenerative glenohumeral joint disease including osteoarthritis (OA), OR post-traumatic arthritis, OR rheumatoid arthritis (RA), OR osteonecrosis, OR arthropathy with rotator cuff deficit when all the following are present: Documented radiographic evidence of the diagnosis (e.g., irregular joint surfaces, subchondral cysts, glenoid flattening or sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, or avascular necrosis); AND Documentation of moderate-to-severe chronic pain OR chronic functional disability for a minimum of 12 weeks; AND Documentation of at least 12 weeks of unsuccessful conservative therapy. (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.)1 Treatment of acute proximal humerus fractures (PHFs) not amenable to conservative therapy or internal fixation Treatment of nonunion or malunion PHFs with radiographic evidence Reconstruction following tumor resection of the glenohumeral joint, proximal humerus, or adjacent tissue Massive irreparable rotator cuff tears (MIRCTs) when all the following are present: Evidence of massive rotator cuff tear (MRCT) by magnetic resonance imaging (MRI) or arthroscopy (e.g., tear size greater than 5 cm in an anterior-posterior or medial-lateral orientation, OR tears of 2 or more tendons, OR retraction of the tendon to the glenoid rim with greater than 2/3 of the greater tuberosity exposed on imaging in the sagittal plane)2 Pseudo-paralysis Documentation of at least 12 weeks of unsuccessful conservative therapy including 12 weeks of supervised physical therapy (PT). (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.) Reverse total shoulder arthroplasty (RTSA) following failed anatomic total shoulder arthroplasty (aTSA) or failed hemiarthroplasty (HA) NOTE: To document unsuccessful conservative therapy, a pain or disability assessment must be performed and documented at baseline and after therapeutic intervention using the same scale for each assessment. The scales used for measurement of pain or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS), Visual Analog Scale (VAS) for pain assessment, Disabilities of the Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeon score (ASES), Simple Shoulder Test (SST), Constant-Murley score, and Western Ontario Rotator Cuff Index (WORC). Limitations of Coverage Provider Qualifications The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers. Patient safety and quality-of-care mandate that healthcare professionals who perform shoulder arthroplasty are appropriately trained and/or credentialed by a formal residency/fellowship program, and/or are certified by either an accredited and nationally recognized organization, or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this LCD. Credentialing and privileges are required for procedures performed in inpatient and outpatient settings. Definitions Conservative therapy: nonoperative treatment that may include 1 or more of the following: Anti-inflammatory medications or analgesics Flexibility and muscle strengthening exercises A trial of supervised PT Corticosteroid injections Pseudo-paralysis: MRCT with active elevation less than 90° against gravity3,4 Total shoulder arthroplasty (also known as total shoulder replacement): a surgical procedure that replaces both the glenoid and proximal humerus with prosthetic parts. This includes both aTSA and RTSA. Summary of Evidence Safety In 2007, Farmer et al. compared the outcomes of shoulder, hip, and knee arthroplasties. They specifically evaluated the inpatient mortality, complications, length of stay, and total charges of patients who had shoulder arthroplasty for OA with those of patients who had hip and knee arthroplasties for OA. A review of the Maryland Health Services Cost Review Commission discharge database identified 994 shoulder arthroplasties, 15,414 hip arthroplasties, and 34,471 knee arthroplasties performed for OA from 1994 to 2001. They found no in-hospital deaths after shoulder arthroplasty, whereas 27 (0.18%) and 54 (0.16%) deaths occurred after hip and knee arthroplasties, respectively. Compared with patients who had hip or knee arthroplasties, patients who had shoulder arthroplasties had, on average, a lower complication rate, a shorter length of stay, and fewer total charges. The latter had 1/2 as many in-hospital complications, were 1/6 as likely to have a length of stay 6 days or greater and were 1/10 as likely to be charged more than $15,000. They concluded shoulder arthroplasty is as safe as the more commonly performed major joint arthroplasties.5 Ahmed et al. performed a 2021 retrospective review comparing readmission rates and postoperative complications in outpatient versus inpatient TSA. Ten level III retrospective studies were included with 7,637 (3.8%) and 192,025 (96.2%) patients undergoing outpatient and inpatient TSA, respectively. Outpatient TSA had relatively younger and healthier patients. There were no differences between outpatient and inpatient arthroplasty for 30- and 90-day readmissions. Furthermore, unadjusted comparisons demonstrated significantly less total and major surgical complications and less total, major, and minor medical complications in favor of outpatient TSA. However, subgroup analyses demonstrated that there were no significant differences in all complications if the studies had matched controls and regardless of data source (database or non-database studies). The revision rates were similar between both groups at a 12–24-month follow-up. Two studies reported a significant reduction in costs in favor of outpatient TSA.6 In 2022, Puzzitiello et al. conducted a systematic review to evaluate the safety and cost of outpatient TSA by assessing associated complication rates, clinical outcomes, and total treatment charges. Of 20 studies identified that met inclusion criteria, 14 were comparative studies involving an inpatient control group, 2 of which were matched by age and comorbidities. The remaining studies used control groups consisting of inpatient TSAs who were older or more medically infirm according to American Society of Anesthesiologists (ASA) or Charlson Comorbidity Index (CCI) scores. The combined average age of the outpatient and inpatient groups was 66.5 and 70.1 years, respectively. Patients who underwent outpatient TSA had similar rates of readmissions, emergency department visits, and perioperative complications in comparison to inpatients. Patients also reported comparably high levels of satisfaction with outpatient procedures. Four economic analyses demonstrated substantial cost savings with outpatient TSA in comparison to inpatient surgery.7 Carter et al. (2012) performed a systematic review and meta-analysis with a focus on preoperative and postoperative health-related quality-of-life (QOL) outcomes for patients receiving TSA. A total of 20 studies (1,576 TSA) met the inclusion criteria. Outcome measures were analyzed after an average postoperative follow-up duration of 3.7 +/- 2.2 years. Significant improvements were observed in the VAS score for pain (standardized mean difference [SMD] = -2.5, p < 0.001) and scores on 3 shoulder-specific measures: the Constant-Murley score (SMD = 2.7, p < 0.001), ASES score (SMD = 2.9, p < 0.001), and SST (SMD = 2.3, p < 0.001). The study concluded that TSA leads to significant improvements in scores for function and pain. Shoulder-specific measures of function consistently showed the greatest degree of improvement, with large effect sizes. They noted that TSA also leads to significant improvements in overall physical well-being, with a moderate-to-large effect size.8 TSA for Glenohumeral Arthropathies A 2012 multi-center, retrospective study by Favard et al. evaluated the rate of complications and the functional improvement with different types of shoulder arthroplasties after a minimum follow-up of 8 years. A total of 198 shoulders including 85 primary OA of the shoulder, 76 rotator cuff tear arthropathies, 19 avascular necrosis, and 18 RA were included in this study. Arthroplasties included 104 aTSA, 77 RTSA, and 17 HAs. Ten arthroplasties were revised, and 134 patients with TSA were able to be present at the final follow-up or provide information on their case. Function was evaluated by the Constant-Murley score and loosening by standard radiographs. In the group with primary OA of the shoulder, there were 8 complications (11%) including 6 (8.3%) requiring implant revision. In the group of rotator cuff arthropathies, there were 9 (14.7%) complications including 4 (6.5%) requiring implant revision. In the group with RA, there was 1 complication, and no surgical revision was necessary. There were no complications in the group with avascular necrosis. Glenoid migration occurred in 28.5% of aTSA, and 3.4% of reverse arthroplasties. This difference was significant (p < 0.001). The Constant-Murley score was significantly improved in all etiologies. The authors concluded that glenohumeral arthropathies can be successfully treated by arthroplasty.9 Fevang et al. (2012) evaluated function, pain, and QOL after shoulder arthroplasty in 4 diagnostic groups. The study included a total of 1,107 patients with shoulder arthroplasties registered in the Norwegian Arthroplasty Register from 1994 through 2008 that were posted a questionnaire in 2010. The diagnoses included RA, OA, acute fracture (AF), or fracture sequela (FS) on returned completed forms (65% response rate). The primary outcome measure was the Oxford shoulder score (OSS), which assesses symptoms and function experienced by the patient on a scale from 0 to 48. A secondary outcome measure was the EuroQol 5 Dimension (EQ-5D), which assesses QOL. The patients completed a questionnaire concerning symptoms 1 month before surgery and another concerning the month before they received the questionnaire. Patients with RA and OA had the best results with a mean improvement in OSS of 16 units, as opposed to 11 for FS patients. Both shoulder pain and function had improved substantially. The change in OSS for patients with AF was negative (-11), but similar end results were obtained for AF patients as for RA and OA patients. QOL had improved in patients with RA, OA, and FS. Good results in terms of pain relief and improved level of function were obtained after shoulder arthroplasty for patients with RA, OA, and, to a lesser degree, FS. A shoulder arthropathy had a major effect on QOL, and treatment with shoulder replacement substantially improved it.10 In 2014, Barlow et al. studied outcomes resulting from 303 consecutive shoulder arthroplasties (108 HAs, 195 TSAs) for RA at 1 institution. Kaplan-Meier survivorship free of revision at 5 years and 10 years was 96.1% and 92.9% for TSA and 89.2% and 87.9% for HA. The most common indications were glenoid loosening (5%) and infection (2%) for TSA revision and glenoid arthrosis (7%) for HA revision. Pain relief was greater with TSA than with HA. In patients with an intact rotator cuff, in comparing TSA with HA, those with a TSA had greater improvements in pain scores and degrees of elevation (45 versus 24) (P = 0.08). Approximately 30% of humeral components and 73% of glenoid components had periprosthetic lucencies. There was a shift in position of the glenoid in 33% of TSAs, and 36% were “at risk.” Eighty-one percent of HAs had moderate or severe glenoid erosion. The study concluded both HA and TSA provide pain relief and improved motion in patients with RA. In patients with an intact rotator cuff, pain relief and range of motion (ROM) were more improved with TSA compared with HA. There was a high rate of component lucency, but component revision is uncommon.11 Lévigne et al. conducted a 2021 retrospective, multicenter study including 65 consecutive, primary reverse shoulder arthroplasties (RSAs) performed in 59 patients with RA. Age at surgery averaged 69 years (range, 46-86 years). A structural bone grafting was performed in 18 cases (45%), using the humeral head in 15 cases (BIO-RSA technique), the iliac crest in 2 cases (Norris technique), and an allograft in 1 case. The mean follow-up was 92 months (range, 60-147 months) or until revision surgery. Revision-free survivorship, using Kaplan-Meier curves, was 96% at 7 years. Two patients had revision surgeries for infections, with associated glenoid loosening in 1 case. No humeral loosening was recorded. The mean adjusted Constant score improved from 36% ± 23% preoperatively to 90% ± 26% postoperatively, and mean subjective shoulder value improved from 21% ± 13% to 85% ± 12%, respectively (P < 0.001). Active anterior elevation increased from 65° ± 43° to 132° ± 27°, active external rotation increased from 10° ± 26° to 22° ± 27°, and internal rotation improved from buttocks to waist (P < 0.001). Stable fixation of the baseplate was achieved in all cases (including the 6 patients with end-stage RA), and bone graft nonunion or resorption was not observed. Preoperative radiologic pattern (centered, ascending, or destructive), presence of acromial fractures or tilt (4 cases, 10%), and scapular notching (55%) on final radiographs were not found to influence outcomes or complication rate. Patients with absent/atrophied teres minor had lower functional results. Overall, 95% of the patients were satisfied with the procedure.12 Guo et al. performed a 2016 study to evaluate the mid-term results of nonsurgical treatment for shoulder OA. This study sought to determine the efficacy of nonsurgical management in older patients with shoulder OA. A total of 129 conservatively treated unilateral shoulder OA patients who were older than 65 years were evaluated prospectively at the initial office visit and then subsequently at 3, 6, 12, 18, 24, and 36 months later. During the 36-month follow-up period, all patients could receive conventional therapy, such as nonsteroidal anti-inflammatory medication, corticosteroid injection, sodium hyaluronate, and education, at the discretion of treating physicians. Some patients received physiotherapy, rehabilitation training, and a shoulder strap to improve the ROM and muscular strength training from a physical therapist. Parameters measured included comparative effectiveness of each therapeutic method, VAS, SST, and Short Form (36) Health Survey (SF-36) scores. At 3-year follow-up, most patients had a significant increase from their pretreatment values in pain, self-assessed shoulder function, mental health, and 5 of 8 SF-36 domains. The study showed a decline in SST and VAS at 6 and 12 months after an initial ascent at 3 months, and then it was rescued and continued at 3-year follow-up. Combined therapy could improve symptoms significantly. This study suggests that a conservative approach may be more appropriate and can produce satisfactory mid-term outcomes in selected cases. The findings of this study suggest that conservative treatments should be extended for longer than 12 months before the decision regarding shoulder arthroplasty is made.1 Treatment of Proximal Humerus Fractures In a large review, Gupta et al. (2015) compared the outcomes of open reduction and internal fixation (ORIF), closed reduction and percutaneous pinning, HA, and RSA for PHFs. They evaluated the clinical outcomes of 4,500 patients after surgical treatment of 3- or 4-part PHFs with a minimum of 1-year follow-up. Levels 1 to 4 studies were eligible for inclusion. Significantly better clinical outcomes were observed for ORIF over HA and RSA (ASES, DASH, Constant) (p < 0.05). However, ORIF had a significantly higher reoperation rate versus HA and RSA (p < 0.001 for both). Comparing HA with RSA, there was no difference in any outcome measure. The rate of tuberosity nonunion was 15.4% in the HA group. The study concluded there were more complications following closed reduction and percutaneous pinning versus ORIF, HA, and RSA (p < 0.05); ORIF for PHFs demonstrated better clinical outcome scores but with a significantly higher reoperation rate; HA and RSA were effective as well, but tuberosity nonunion remains a concern with HA.13 Dezfuli et al. (2016) studied the outcomes of RTSA for PHF in differing clinical scenarios. These investigators evaluated outcomes of all patients with PHFs treated with RTSA as a primary procedure for acute PHF, a delayed primary procedure for symptomatic PHF malunion or nonunion, a revision procedure for failed PHF HA, or a revision procedure for failed ORIF. Patients who underwent RTSA for PHF were evaluated using multiple approaches. RTSA was performed in 49 patients with PHF; 13 patients underwent RTSA for acute PHF, 13 for malunion or nonunion, 12 for failed PHF HA, and 11 for failed PHF ORIF; external rotation (ER) ROM, SPADI, ASES, UCLA, and Constant scores achieved significance. The acute fracture group significantly outperformed the failed HA group in SPADI, ASES, and UCLA scores. The malunion/nonunion group significantly outperformed the failed HA group in ASES and UCLA scores. The acute fracture and malunion/nonunion groups each had significantly greater ER than the failed HA group. Results showed that RTSA is an effective treatment option for PHF as both a primary and a revision procedure. Primary RTSA outperformed RTSA done as a revision procedure; RTSA for acute PHF is comparable to RTSA for malunions and nonunions.14 Torchia and colleagues (2019) performed a meta-analysis to compare the outcomes of acute RTSA for fracture and delayed RTSA for fracture sequelae. Investigators calculated weighted mean differences for ROM, SMDs for clinical outcome scores, and relative risks (RR) for dichotomous outcomes. Including 16 studies, a total of 322 patients underwent RTSA for fracture sequelae. Of these studies, 4 were comparative (46 patients) whereas 12 were case series (276 patients). Among studies directly comparing acute versus delayed RTSA, no differences in forward flexion (p = 0.72), clinical outcome scores (p = 0.78), or all-cause reoperation (p = 0.92) were found between the 2 groups. Patients undergoing delayed RTSA achieved 6° more ER than those undergoing acute RTSA; this difference was significant (p = 0.01). The researchers concluded that given the risks associated with surgery in the elderly population, consideration may be given to an initial trial of nonoperative treatment in these patients, saving RTSA for those in whom nonoperative treatment failed without compromising the ultimate outcome.15 A 2020 study by Yahuaca et al. compared patient and fracture characteristics with outcomes between current surgical treatment options. It included 425 PHFs that underwent acute surgical management: ORIF (n = 211), HA (n = 108), or RSA (n = 106). Outcomes showed a significant improvement in forward flexion from 3 months to 6 months in all groups (P < 0.0001). No difference in final motion was seen between groups. Radiographic union was higher in ORIF (89%), and similar between HA (79%) and RSA (77%, P = 0.005). Rate of reoperation was RSA 6.6%, ORIF 17.5%, and HA 15.7% (P = 0.029). Postoperatively, 23% of patients had at least 1 fall, of which 73% resulted in fractures. The overall conclusion was older patients with high ASA (American Society of Anesthesiologists physical status classification) were treated with arthroplasty, and younger patients with lower ASA were treated with ORIF. All groups showed improvements in motion. At minimum 1 year of follow-up, there was no difference in motion between groups. ORIF and HA showed significantly more reoperations compared with RSA. Patients should be counseled about reoperation, fall risk, and prevention.16 Lu et al. conducted a 2023 systematic review and meta-analysis comparing the outcomes of acute RSA and delayed RSA for the treatment of PHFs in the elderly. The review included 16 studies and 11,829 shoulders for PHFs. Compared with delayed RSA cohorts, acute RSA cohorts had higher forward flexion (124.3° vs. 114.9°; P = 0.019), ER (24.7° vs. 20.2°; P = 0.041), and abduction (113.2° vs. 99.8°; P = 0.03). Compared with RSA after conservative management, acute RSA had greater ER (29.9° vs. 21.4°; P = 0.043). The acute RSA cohort had significantly higher ASES (76.4 vs. 68.2; P = 0.025) and Constant-Murley scores (65.6 vs. 57.3; P = 0.002) compared with the delayed RSA cohort. Subgroup analyses showed significantly greater Constant-Murley (64.9 vs. 56.9; P = 0.020) and SST scores (8.8 vs. 6.8; P = 0.031) with acute RSA compared with RSA after conservative treatment. The ASES score was higher in the acute RSA cohort compared with RSA after ORIF (77.9 vs. 63.5; P = 0.008). The overall complication rate per 100 patient-years was 11.7 for the acute RSA cohort and 18.5 for the delayed RSA cohort (risk ratio: 0.55; P = 0.015). The current evidence suggests acute RSA presents better clinical outcome measures and ROM measurements, with decreased complication rates than RSA performed after prior nonoperative or operative treatment.17 TSA for Oncologic Reconstruction of the Proximal Humerus Trovarelli retrospectively analyzed only patients treated with modular RTSA after proximal humerus resection. From January 2011 to January 2018, these investigators treated 52 patients for bone tumors of the proximal humerus. There were 22 patients, with a mean (range) age of 55 years (18 to 71). Complications and function were evaluated at final follow-up by the treating surgeon and shoulder surgeon. Complications were evaluated according to Henderson classification. Functional results were assessed with the Musculoskeletal Tumor Society (MSTS) score (range of 0 points to 30 points), Constant-Murley score (range 0 to 100), and ASES score (range of 0 to 100); statistical analysis was carried out using Kaplan-Meier curves. Complications occurred in 5 of 22 patients; there was a shoulder dislocation (Type I) in 4 patients and aseptic loosening (Type II) in 1 patient. Function in these patients on the outcomes scales was generally satisfactory; the mean MSTS score was 29, the mean Constant score was 61, and the mean ASES score was 81. The study concluded that although this was a small series of patients with heterogeneous diagnoses and resection types, they found patients treated with RTSA achieved reasonable shoulder function after resection and reconstruction of a proximal humerus tumor. It may not be valuable in all tumor resections, but in patients in whom the deltoid can be partly spared, this procedure appeared to reasonably restore short-term shoulder function.18 Ferlauto et al. conducted a systematic review to identify studies that reported outcomes of patients who underwent RTSA for oncologic reconstruction of the proximal humerus. A total of 12 studies were included, containing 194 patients who underwent RTSA for oncologic reconstruction of the proximal humerus. The mean patient age was 48 years, and 52% of patients were men. Primary malignancies were present in 55% of patients; metastatic disease, 30%; and benign tumors, 9%. The mean humeral resection length was 12 cm. The mean postoperative MSTS score was 78%; Constant score, 60%; and Toronto Extremity Salvage Score, 77%. The mean complication rate was 28%, with shoulder instability accounting for 63% of complications. Revisions were carried out in 16% of patients, and the mean implant survival rate was 89% at a mean follow-up across studies of 53 months. The authors concluded that although the existing literature is of poor study quality, with a high level of heterogeneity and risk of bias, RTSA appeared to be a suitable option in appropriately selected patients undergoing oncologic resection and reconstruction of the proximal humerus. The most common complication was instability.19 Aiba et al. conducted a literature search on various types of proximal humerus oncologic reconstruction methods including modular prosthesis (752 patients in 21 articles), osteoarticular allograft (142 patients in 6 articles), allograft prosthesis composites (236 patients in 12 articles), RSTA (141 patients in 10 articles), composite RSTA (33 patients in 4 articles), claviculo-pro-humero technique (51 patients in 6 articles), and cement spacer (207 patients in 4 articles). Weighted mean MSTS scores were modular prosthesis (73.8%), osteoarticular allograft (74.4%), allograft prosthesis composites (79.2%), RSTA (77.0%), composite RSTA (76.1%), claviculo-pro-humero technique (75.1%), and cement spacer (69.1%). Weighted 5-year reconstruction survival rates were modular prosthesis (85.4%), osteoarticular allograft (67.6%), allograft prosthesis composites (85.2%), RSTA (84.1%), and cement spacer (88.0%). Major complications included shoulder joint instability: modular prosthesis (26.2%), osteoarticular allograft (41.5%), allograft prosthesis composites (33.9%), RSTA (17%), composite RSTA (6.1%), claviculo-pro-humero technique (2.0%), and cement spacer (8.7%). Aseptic loosening of the prosthesis occurred: modular prosthesis (3.9%) and RSTA (5.7%). Allograft fracture was observed in 54.9% of patients with osteoarticular allograft. The complication profiles differed among reconstruction methods. With a focus on RTSA, the weighted mean MSTS was 77% and the 5-year reconstruction survival rate was 84.1%. The study concluded proximal humerus reconstruction after bone tumor resection should consider potential complications and patients' individual factors.20 TSA for Massive Irreparable Rotator Cuff Tears In order to develop a standard definition for MRCTs, Schumaier et al. used a modified Delphi technique to determine a practical, consensus definition for MRCTs. The study was based on responses from 20 experts who participated in 4 rounds of surveys to determine a consensus definition for MRCT. The following core characteristics reached consensus in the first round: tear size, number of tendons torn, and degree of medial retraction. MRI and intraoperative findings reached consensus as the modalities of diagnosis. The second round determined that tear size should be measured as a relative value. An initial definition for MRCT was proposed in the third round: retraction of tendon(s) to the glenoid rim and/or a tear with ≥67% greater tuberosity exposure (65% approval). A modified definition was proposed that specified degree of retraction should be measured in the coronal or axial plane and the amount of greater tuberosity exposure should be measured in the sagittal plane (90% approval). The study determined with 90% agreement that MRCT should be defined as retraction of tendon(s) to the glenoid rim in either the coronal or axial plane and/or a tear with ≥67% of the greater tuberosity exposed measured in the sagittal plane. The measurement can be performed either with MRI or intraoperatively.2 Tokish et al. performed a systematic review and meta-analysis including studies that defined a preoperative shoulder group as having pseudo-paralysis. A secondary search included preoperative active forward elevation (AFE) less than 90°. In 16 studies, the most consistent definition was a MRCT with active elevation less than 90°, but studies inconsistently included stiffness, ER loss, arthritic changes, neurologic status, and pain. There were 6 different techniques: nonoperative rehabilitation, rotator cuff repair, muscle transfer, HA, RTSA, and RTSA with muscle transfer. Postoperatively, all approaches showed improvement.3 Dickerson et al. conducted a 2020 systematic review of shoulder pseudo-paralysis due to MRCTs. Nine articles evaluating RTSA, superior capsular reconstruction (SCR), and rehabilitation programs were included in the study. Though there was variability, the definition of pseudo-paralysis was AFE less than 90° with preserved passive ROM. Reversal of pseudo-paralysis was defined as restoration of AFE greater than 90°. The overall rate of reversal of pseudo-paralysis across studies was similar for RTSA (96% ± 17%) and SCR (94% ± 3%). However, there was a difference in average improvement in AFE for RTSA (56° ± 11°) and SCR (106° ± 20°). A progressive rehabilitation program described improvements in a single study with 82% reversal of pseudo-paralysis.4 Shepet et al. conducted a 2021 comprehensive review of literature involving clinical outcomes of nonoperative treatment of MIRCTs. A total of 10 studies met inclusion criteria. Multiple studies showed significant improvement. Several studies demonstrated significant improvements in strength and ROM. The overall success of nonoperative treatment ranged from 32%-96%. The synthesized nonoperative treatment protocol is characterized by requiring some supervised PT, often requiring 12 weeks or more, focusing on supine exercises with gradual progression to upright. Corticosteroid injections and nonsteroidal anti-inflammatory drugs may also be of benefit. The study concluded nonoperative treatment has been shown to be efficacious for patients with chronic MIRCTs.21 Virk et al. performed a 2016 review of the current understanding of the role of RTSA for the management of irreparable rotator cuff tears without arthritis combining the author’s personal experience and available scientific literature. RTSA is a constrained arthroplasty system that can allow the deltoid and remaining rotator cuff to substitute for the lost function of irreparable rotator cuff. Furthermore, the pain relief is consistent with often a dramatic improvement in patient comfort, shoulder function and stability. In patients with pseudo-paralysis of the shoulder without advanced arthritis, RTSA effectively restored forward elevation above the shoulder but may not dramatically improve external or internal rotation. The authors advised caution when using RTSA for symptomatic irreparable rotator cuff tears with preserved AFE and in patients less than 65 years of age. Patients without pseudo-paralysis can have a higher complication and dissatisfaction rate. They otherwise concluded that RTSA is a reasonable surgical option for irreparable rotator cuff repair without arthritis.22 In a 2017 systematic review, Petrillo et al. reported the outcomes and complications of RSA in MIRCTs and cuff tear arthropathy (CTA). They performed a systematic review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All articles reporting outcomes and complications of RSA for the management of MIRCT or CTA were included. The comparison between preoperative and postoperative clinical scores, as well as ROM, was performed using the Wilcoxon-Mann-Whitney test; p values lower than 0.05 were considered statistically significant. A total of 7 articles were included in this qualitative synthesis. A statistically significant improvement in all clinical scores and ROM was found comparing the preoperative value with the postoperative value. The degrees of retroversion of the humeral stem of the RSA did not influence the functional outcomes in a statistically significant fashion. There were 17.4% of complications. The most frequent was heterotopic ossification, occurring in 6.6% of patients. Revision surgery was necessary in 7.3% of patients. The authors concluded that RSA restored pain-free ROM and improved function of the shoulder in patients with MIRCT or CTA. However, complications occurred in a high percentage of patients. They stated that the lack of level I studies limited the real understanding of the potentials and limitations of RSA for the management of MIRCT and CTA.23 Sevivas et al. performed a 2017 systematic review evaluating MRCTs. RSA is an option that can provide a more predictable pain relief and recovery of function. The goal of the study was to better define outcomes after RSA for MIRCT. Included were 6 studies (266 shoulders) with a follow-up ranging from 24 to 61.4 months. The mean Coleman Methodology score was 58.2 ± 11.8 points. There was an overall improvement from preoperative to postoperative assessments of the clinical score (Cohen d = 1.35, p < 0.001), forward flexion (d = 0.50, p = 0.009), ER (d = 0.40, p < 0.001), function (d = 1.04, p < 0.001), and pain (d = -0.89, p < 0.001). The study concluded that patients with MIRCT without presence of OA have a high likelihood of achieving a painless shoulder and functional improvements after RSA.24 Evaluating treatments for MIRCTs, Kang et al. (2017) compared RTSA versus other therapies including PT, arthroscopic debridement with biceps tenotomy (AD-BT), and HA. A cost-effectiveness analysis of these interventions has never been performed, and no head-to-head comparative effectiveness trials currently exist. In this study, a Markov decision analytic model was used to compare RTSA, HA, AD-BT, and PT as treatments for elderly patients with MIRCT. RTSA yielded the most quality-adjusted life years (QALY) with 7.69, but greater benefits came at higher costs compared with other treatments. Sensitivity analyses showed that PT was the most cost-effective intervention at a health-utility of 0.75 or greater (QALY 7.35). The health-utility of RTSA was 0.72 or less (QALY 7.48) or RTSA probability of no complications was 0.83 or less (QALY 7.48 at cost of $23,830). The study concluded RTSA yielded benefits at a cost considered good value for money compared with other treatments. RTSA is the preferred and most cost-effective treatment option for elderly patients with MIRCTs. For patients seeking pain relief without functional gains, AD-BT can be considered a cost-effective and cheaper alternative.25 Ardebol et al. performed a 2024 systematic review using RTSA for MIRCTs and evaluated the impact of prior attempted rotator cuff repair (RCR) on outcomes. Seven studies were included in the analysis, consisting of 343 cases in the primary RSA group and 95 cases in the prior RCR group, with a mean follow-up of 40.8 months. There were no demographic differences between cohorts. Postoperative patient-reported outcome measures (PROMs) and ROM were comparable between groups, although the prior RCR group had a higher maximal percentage of improvement (MPI%) for the Constant-Murley Score and SST. There was a higher risk for complications (RR 6.26) and revisions (RR 3.91) in the prior RCR group. The most common complications were acromial stress fractures and prosthetic dislocation. The study concluded that patients undergoing RSA for MIRCT following a prior RCR have functional outcomes that are largely comparable to those who have a primary RSA, but they may be at higher risk of complications and revision.26 Analysis of Evidence (Rationale for Determination) TSA is a well-established treatment for various painful and debilitating shoulder conditions. It can provide pain relief, improve function, reduce disability, and enhance QOL. The shoulder joint is the third most commonly replaced joint after the hip and knee, and in the United States (U.S.), the rate of primary shoulder arthroplasties has increased 103.7% between 2011 and 2017.27 The overall safety of surgery is well documented and is comparable to knee and hip arthroplasty.5 Recent studies have suggested TSA may be performed safely and efficiently as an outpatient in properly selected patients.6,7 Although anatomic and reverse arthroplasty have differing indications, these are not differentiated in this LCD, and the choice is left to the clinician. While this surgery can improve the QOL for many individuals, it is not without risks and complications. Some of these complications include dislocation, fracture, implant loosening, nerve injury, and infection. Therefore, it is advisable to offer patients a reasonable trial of conservative or nonoperative therapies before considering TSA, unless specific circumstances prohibit such an approach. The above research shows strong support for utilization of TSA in patients with destructive or degenerative disease involving the shoulder joint when conservative therapy is unsuccessful or not appropriate. The greatest benefits are seen in individuals most affected by pain and functional loss. This emphasizes the importance of proper patient selection.9-12 Various approaches exist in the literature for managing PHFs and reconstructing the proximal humerus or glenohumeral joint after resection. Both conditions put patients at risk for considerable pain and functional loss. Current research supports TSA as a potential treatment option when clinically indicated.13-20 The literature reports multiple approaches to address MIRCT, including PT, AD-BT, HA, and RTSA. While all these approaches have demonstrated varying degrees of improvement, RTSA seems to offer “predictable pain relief and recovery of function.”24 However, there have been relatively high levels of complications in some studies23 and higher levels of complications and dissatisfaction in patients without pseudo-paralysis.22 PT has classically been a mainstay of MIRCT treatment, and research supports its utilization for initial management for most patients.3,4,21,25 A review of the literature shows variations in the definition of pseudo-paralysis, but the majority of studies have included patients with a MRCT with AFE less than 90° against gravity3-4, thus being the definition used in this LCD. TSA has the potential to provide significant benefits in the Medicare population. Maintaining access to this procedure is crucial for those needing relief from the pain and disability associated with shoulder dysfunction. Regarding patient selection, careful consideration and risk assessment is encouraged to minimize risks and complications.

Indications of Coverage Total shoulder arthroplasty (TSA) is reasonable and necessary for each of the following conditions: Degenerative glenohumeral joint disease including osteoarthritis (OA), OR post-traumatic arthritis, OR rheumatoid arthritis (RA), OR osteonecrosis, OR arthropathy with rotator cuff deficit when all the following are present: Documented radiographic evidence of the diagnosis (e.g., irregular joint surfaces, subchondral cysts, glenoid flattening or sclerosis, periarticular osteophytes, joint subluxation, joint space narrowing, or avascular necrosis); AND Documentation of moderate-to-severe chronic pain OR chronic functional disability for a minimum of 12 weeks; AND Documentation of at least 12 weeks of unsuccessful conservative therapy. (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.) 1 Treatment of acute proximal humerus fractures (PHFs) not amenable to conservative therapy or internal fixation Treatment of nonunion or malunion PHFs with radiographic evidence Reconstruction following tumor resection of the glenohumeral joint, proximal humerus, or adjacent tissue Massive irreparable rotator cuff tears (MIRCTs) when all the following are present: Evidence of massive rotator cuff tear (MRCT) by magnetic resonance imaging (MRI) or arthroscopy (e.g., tear size greater than 5 cm in an anterior-posterior or medial-lateral orientation, OR tears of 2 or more tendons, OR retraction of the tendon to the glenoid rim with greater than 2/3 of the greater tuberosity exposed on imaging in the sagittal plane) 2 Pseudo-paralysis Documentation of at least 12 weeks of unsuccessful conservative therapy including 12 weeks of supervised physical therapy (PT). (If conservative therapy is not appropriate, the medical record must clearly document why such approach is not reasonable.) Reverse total shoulder arthroplasty (RTSA) following failed anatomic total shoulder arthroplasty (aTSA) or failed hemiarthroplasty (HA) NOTE: To document unsuccessful conservative therapy, a pain or disability assessment must be performed and documented at baseline and after therapeutic intervention using the same scale for each assessment. The scales used for measurement of pain or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS), Visual Analog Scale (VAS) for pain assessment, Disabilities of the Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeon score (ASES), Simple Shoulder Test (SST), Constant-Murley score, and Western Ontario Rotator Cuff Index (WORC). Limitations of Coverage Provider Qualifications The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers. Patient safety and quality-of-care mandate that healthcare professionals who perform shoulder arthroplasty are appropriately trained and/or credentialed by a formal residency/fellowship program, and/or are certified by either an accredited and nationally recognized organization, or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this LCD. Credentialing and privileges are required for procedures performed in inpatient and outpatient settings. Definitions Conservative therapy: nonoperative treatment that may include 1 or more of the following: Anti-inflammatory medications or analgesics Flexibility and muscle strengthening exercises A trial of supervised PT Corticosteroid injections Pseudo-paralysis: MRCT with active elevation less than 90° against gravity 3,4 Total shoulder arthroplasty (also known as total shoulder replacement): a surgical procedure that replaces both the glenoid and proximal humerus with prosthetic parts. This includes both aTSA and RTSA.