National Medical Policy Subject: Shoulder Arthroplasty Policy Number: NMP222 Effective Date*: July 2005 Updated: September 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other X None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. Shoulder Arthroplasty Sep 15 1
If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement I. Health Net, Inc. considers shoulder arthroplasty medically necessary when any of the following is met: 1. Patient has shoulder pain due to osteoarthritis (degenerative disease) or rheumatoid arthritis and all of the following: OR Patient s symptoms significantly interfers with activities of daily living; and Patient with osteoarthritis unresponsive to all of the following conservative treatments that have been attempted for at least 6 months: Activity restrictions Aspirin or acetaminophen Nonsteroidal anti-inflammatory drugs (NSAIDs) Physical Therapy Glucocorticoids by intra-articular injection; Patient with rheumatoid arthritis unresponsive to each of the following conservative treatments that have been attempted for > 6 weeks: Activity restrictions (eg. Resting the shoulder and applying moist heat for mild pain); Physical Therapy (eg. This may helpful when arthritis is in the early stages. Physical therapy is less effective when the arthritis has advanced to the point that bone rubs on bone. When this is the case, physical therapy may make the shoulder hurt more, and would not be advised). AND one or more of the following: Disease modifying antirheumatic drugs (DMARDS); or Immunosuppressive drugs; or Anticytokine agents (infliximab-remicade, Etanercept-Enbrel). 2. Repair of complex fracture of proximal humerus 3. Rotator cuff arthropathy 4. Avascular necrosis 5. Failed shoulder prosthesis Health Net, Inc. considers shoulder arthroplasty contraindicated in the presence of active systemic or articular infection. Note: The postoperative use of Continuous Passive Motion (CPM) devices is considered not medically necessary for shoulder arthroplasty. (Please refer to the Shoulder Arthroplasty Sep 15 2
Health Net, Inc. National Medical Policy on Continuous Passive Motion (CPM) Devices ) II. Health Net, Inc. considers reverse shoulder arthroplasty for severe shoulder pain unresponsive to other treatments, medically necessary for any of the following indications: 1. Deficient irreparable rotator cuff with glenohumeral arthropathy; or 2. Massive rotator cuff tear with pseudoparalysis; or 3. Severe inflammatory arthritis with a massive cuff tear; or 4. Failed total shoulder arthroplasty or hemiarthroplasty with irreparable rotator cuff deficiency; or 5. Proximal humeral fracture that are not repairable or cannot be reconstructed with other techniques; or 6. Reconstruction after a tumor resection. Note: The individual should have an intact deltoid, adequate bone stock to support the glenoid component, no evidence of infection, no severe neurological deficiency (Parkinson disease, Charcot joints, syringomyelia), and no excessive demands on the shoulder joint Definitions TSA RSA CTA Total shoulder arthroplasty Reverse total shoulder arthroplasty Rotator cuff tear arthropathy Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes 714.0 Rheumatoid Arthritis 715.91 Osteoarthrosis, unspecified whether generalized or localized, shoulder region 716.91 Arthropathy, unspecified, shoulder region 812.00 Fracture of humerus, upper end closed, unspecified part Shoulder Arthroplasty Sep 15 3
ICD-10 Codes M06.80-M06.819 M12.811-M12.819 M13.811-M13.819 M19.011-M19.019 M19.111-M19.119 M19.211-M19.219 S42.201-S42.296 Other specified rheumatoid arthritis, shoulder Other specific arthropathies, not elsewhere classified, shoulder Other specified arthritis, shoulder Primary osteoarthritis, shoulder Post-traumatic osteoarthritis, shoulder Secondary osteoarthritis, shoulder Unspecified fracture of upper end of humerus CPT Codes 23470 Arthroplasty, glenohumeral joint; hemiarthroplasty 23472 Arthroplasty, glenohumeral joint; total shoulder (glenoid and Proximal humeral replacement) 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 HCPCS Codes Not applicable Scientific Rationale Update September 2015 Wang et al. (2015) completed a systematic meta-analysis and review with the goal to critically compare the outcome of reverse shoulder arthroplasty versus hemiarthroplasty for the treatment of complex proximal humeral fracture. Studies that investigated and compared the effectiveness or complications in both groups and provided sufficient data of interest were included in this meta-analysis. Participants in both groups were significantly the same in the demography and injury mechanism. Eight studies that fulfilled inclusion and exclusion criteria were included in this meta-analysis, which included 421 participants in hemiarthroplasty (HA) and 160 in reverse shoulder arthroplasty (RSA). Patients were followed-up for at least one year in each study. Compared with HA, RSA was associated with a lower rate of total complications, higher American Shoulder and Elbow Surgeons (ASES) score, more healed tuberosities and improved active forward elevation. Both treatments were comparable in term of revision surgeries, mortality, subjective satisfaction and active external rotation. The present evidence from this metaanalysis suggested that RSA was a more advantaged method for the treatment of complex proximal humeral fractures. Clinical decision should be preferred to RSA on the condition that patients' medical conditions are indicated. Schairer et al. (2015) completed a study that used the Nationwide Inpatient Sample database for 2011, which allows national estimates of inpatient hospital discharges. Most proximal humerus fractures are treated nonoperatively, however, complex 3- and 4-part fractures may require shoulder arthroplasty. Hemi-shoulder arthroplasty (HSA) has been the standard treatment, but recently there has been discussion and utilization of reverse total shoulder arthroplasty (RTSA) as a viable treatment option. This study evaluated the national utilization of RTSA and HSA for proximal humerus fractures and compared patient and hospital characteristics associated with each procedure. Patients were selected by diagnosis and procedure codes to identify those who underwent reverse total shoulder arthroplasty (RTSA) or hemi-shoulder arthroplasty (HAS) for treatment of proximal humerus fractures. Patient and hospital Shoulder Arthroplasty Sep 15 4
characteristics associated with each procedure as well as in-hospital complication rates were identified. An estimated 7714 patients with proximal humerus fractures were selected, 27.4% of whom were treated with RTSA. Except for increased age, patient characteristics were similar between groups, as were complication rates. RTSA was more likely to be performed over HSA in small, rural, nonteaching hospitals and also in those that had already adopted and performed a high volume of RTSA procedures for other diagnoses. Although HSA remains the most common arthroplasty choice for proximal humerus fractures, RTSA is becoming widely used. Patient characteristics and complications were similar between the 2 procedures, and as clinical evidence appears to show improved outcomes with RTSA, it is likely that acceptance of RTSA will continue to grow. Scientific Rationale Update September 2014 According to the American Academy of Orthopedic Surgeons, conventional total shoulder replacement may not be beneficial to individuals with large rotator cuff tears who develop complex shoulder arthritis (i.e., cuff tear arthropathy). Rotator cuff arthropathy is characterized by pain, poor active motion, near-normal passive motion, crepitus, weakness, and occasionally significant fluid buildup under the deltoid. The AAOS states that for individuals with rotator cuff arthropathy, conventional total shoulder replacement may result in pain and limited motion, and reverse total shoulder replacement may be an alternative option. In a healthy shoulder, the rotator cuff muscles help position and power the arm during range of motion. A conventional replacement device also uses the rotator cuff muscles to function properly. In a patient with a large rotator cuff tear and cuff tear arthropathy, these muscles no longer function. The reverse total shoulder replacement relies on the deltoid muscle, instead of the rotator cuff, to power and position the arm. The reverse shoulder prosthesis is a semiconstrained glenohumeral joint prosthesis with a reverse ball and socket configuration. The design moves the center of rotation distal and medial compared with the anatomic center of rotation, and this positioning improves control of the three parts of the deltoid muscle over humeral motion. The goal of reverse shoulder arthroplasty (RSA) is to stabilize the joint, restore joint mobility, and to reduce shoulder pain. Levy et al (2014) investigated the speed of recovery and compared the effectiveness of primary total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA.) The authors analyzed (preoperative, 3 month, 6 month, 1-year, and 2-year scores) pain scores, functional scores, and motion for 122 patients treated with primary RSA and 166 patients treated with primary TSA with a minimum of 1 year of follow-up. Comparisons were made to determine the effectiveness of treatment, time required to reach a plateau in improvement, and percentage of overall improvement at 3 and 6 months. Significant improvements were observed for both TSA and RSA at all intervals (P <.001), except with internal rotation for RSA. Pain relief was rapid after both TSA and RSA. TSA patients reached a consistent plateau for pain and function by 6 months and for shoulder elevation by 1 year. RSA patients demonstrated variability with multiple false plateau points. By 6 months, TSA patients had achieved 90% to 100% of functional improvement, whereas RSA patients reached 72% to 91%. The effectiveness of TSA was greater than that of RSA for all measures with the exception of elevation and abduction. The investigators concluded whereas patients treated with primary TSA and RSA can expect rapid improvements in pain, those treated with TSA can anticipate a more Shoulder Arthroplasty Sep 15 5
consistent and effective recovery of pain, function, and shoulder rotation. Patients receiving RSA can expect a variable length of recovery with greater improvements in forward elevation and abduction. Bonnevialle et al (2014) evaluated midterm outcomes of reverse shoulder arthroplasty (RSA) as an alternative for shoulder girdle reconstruction after wide transarticular resection of the proximal humerus for malignant tumor. Ten patients with RSA were included and reviewed with 24 months of minimum follow-up. Proximal resection of malignant tumor included the "V" deltoid insertion in 4 patients. The humeral stem was coated (with an allograft in 2 patients and a cement mantel in 3) or left uncoated (5 patients). At a mean follow-up of 42 months, among 8 prosthesis available for evaluation (2 patients died), the Constant and Murley score averaged 52 points, the 11-item version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score averaged 29.5 points, the Subjective Shoulder Value averaged 58%, and the Musculoskeletal Tumor Society score averaged 20.25 points. Mean forward active elevation reached 122, external rotation at side was -2, and internal rotation was to L4. Three prostheses were unstable. The involvement of "V" deltoid insertion at surgery trended to worsen the clinical outcome. Atrophy of the anterior deltoid occurred in most of patients who had a previous transdeltoid biopsy. Radiographic evaluation found 1 stem loosening, 1 stem at risk, and 3 scapular notches without glenoid loosening. Investigators concluded use of RSA after resection of a malignant tumor of the proximal humerus seems to be an acceptable option to preserve function. However, radiographic evolution is worrisome, and long-term study remains necessary to validate this therapeutic option with follow-up. Kaa et al (2013) investigated the functional outcome in patients who underwent reverse shoulder replacement (RSR) after removal of a tumor of the proximal humerus. A total of 16 patients (ten women and six men) underwent this procedure between 1998 and 2011 in our hospital. Five patients died and one was lost to follow-up. Ten patients were available for review at a mean follow-up of 46 months (12 to 136). Eight patients had a primary and two patients a secondary bone tumour. At final follow up the mean range of active movement was: abduction 78 (30 to 150 ); flexion 98 (45 to 180 ); external rotation 32 (10 to 60 ); internal rotation 51 (10 to 80 ). The mean Musculoskeletal Tumor Society score was 77% (60% to 90%) and the mean Toronto Extremity Salvage Score was 70% (30% to 91%). Two patients had a superficial infection and one had a deep infection and underwent a two-stage revision procedure. In two patients there was loosening of the RSR; one dislocated twice. All patients had some degree of atrophy or pseudoatrophy of the deltoid muscle. Authors concluded use of a RSR in patients with a tumor of the proximal humerus gives acceptable results. Chalmers et al (2014) reported significant controversy surrounds optimal treatment of displaced 4-part proximal humeral fractures. RSA has recently been proposed as an alternative to hemiarthroplasty (HA) and open reduction-internal fixation (ORIF). The authors compared outcomes RSA, HA, and ORIF. They prrospectively evaluated patients who underwent RSA for displaced 3- and 4-part proximal humeral fractures and then retrospectively developed age- and sex-matched control groups with 3- and 4-part proximal humeral fractures who underwent HA and ORIF. Range of motion including active forward elevation and external rotation and time to achieve active forward elevation >90 were recorded. American Shoulder and Elbow Surgeons (ASES), Short-Form 12-item (SF-12), and Simple Shoulder Test (SST) scores were recorded. In addition, treatment cost was assessed by Medicare data and implant list Shoulder Arthroplasty Sep 15 6
prices. Thes study enrolled 27 patients; 9 underwent RSA, 9 HA, and 9 ORIF. Minimum follow-up was 1 year. No significant differences were seen in SST, ASES, or SF-12 scores. Significantly more patients achieved >90 of active forward elevation after RSA (P =.012. The authors concluded in this case-control study, RSA appears to provide superior range of motion earlier and more predictably than HA and ORIF. Kaisidis et al (2014) evaluated the functional and radiographic results after primary RSA of three- or four-part fractures of the proximal humerus in patients older than 75 years old. Between 2008 and 2010, 29 consecutive patients with a three- or fourpart fracture of the proximal humerus undergoing a reversed shoulder prosthesis were included. There were 16 women and 13 men, with a mean age of 81 years (range 78 to 85). The dominant arm was involved in 18 patients (62%). All of the operations were carried out within 10 days of the injury. The patients were followed up for a mean of 26 months (range 10 to 36). The mean postoperative Constant- Murley score at the end of the follow-up period for each patient (age- and gendermatched) was 73.3% (range 58 to 92%). The mean Constant score was 75% in the group of patients with fixation of the tuberosities and 72.3% in the patients with no fixation of the tuberosities (p = 0.06). There was no significant difference in Constant score between patients who were operated by the fifth day after the fracture and patients who had an operation between the sixth and tenth day after the injury (Constant score of 74% and 71%, respectively, p = 0.07). Complications occurred in 12 patients. One patient sustained a fracture of the acromion intraoperatively. Four patients (13.8%) developed heterotopic ossification. One had a nontraumatic anterior dislocation due to wrong retroversion of the glenoid component. Scapular notching was observed in six shoulders (20.6%). Acevedo et al (2014) compared the use of reverse and hemishoulder arthroplasty for the treatment of proximal humeral fractures among orthopedic surgeons taking part II of the American Board of Orthopaedic Surgery board examination. The authors hypothesized that the use of reverse shoulder arthroplasty for fractures in the elderly is increasing amongst newly trained orthopedic surgeons. They queried the American Board of Orthopaedic Surgery database for the cases of proximal humeral fractures treated with arthroplasty submitted between 2005 and 2012. They evaluated the prosthesis used, patient-specific factors, complications, and the difference in use by shoulder fellowship-trained surgeons. From 2005 to 2012, 5395 board-eligible orthopedic surgeons submitted cases to the database. Of these, 435 (mean, 54 per year) were proximal humeral fractures treated with arthroplasty. The overall incidence of reverse shoulder arthroplasty for fracture increased from 2% to 4% during 2005 to 2007 to 38% in 2012. Shoulder surgeons treated 5 times more proximal humeral fractures with shoulder arthroplasty and were also more than 20 times more likely to use a reverse implant (P <.0001). The difference in complication rates between reverse and hemishoulder arthroplasty was not significant (P =.49). Patients who received a hemiarthroplasty tended to be younger (mean age, 70.8 vs 75.7 years; P =.0015). The authors concluded overall, the use of a hemiarthroplasty for fracture is still more common (62% in 2012), although the relative proportion of reverse implants is rising. Among shoulder surgeons, more than 50% of the arthroplasties performed for fractures during the past 3 years (2010-2012) have been reverse arthroplasties. Baudi et al (2014) compared functional and radiographic results of reverse prosthesis versus hemiarthroplasty after complex displaced proximal humeral fractures in elderly patients when adequate ORIF cannot be achieved and prosthetic shoulder replacement is required. From 2008 to 2012, 67 patients were treated with Shoulder Arthroplasty Sep 15 7
hemiarthroplasty or reverse arthroplasty. The authors evaluated 53 cases with an average follow-up of 27.5 months (range 12-64). Twenty-eight patients with an average age of 71.4 years were treated with a hemiarthroplasty and 25 patients with an average age of 77.3 years with a reverse prosthesis. All patients were assessed before and after surgery by Constant-ASES-DASH score, strength in abduction, ER1, ER2, and X-rays. In hemiarthroplasty group, a mean Constant score of 42.3 pt, ASES score 51.3 pt, and DASH score 46.1, with an average strength of 1.3 lb in abduction and of 3.7 lb in ER1 and 1.8 lb in ER2 was observed. In reverse arthroplasty group, a mean Constant of 56.2 pt, ASES 69.3 pt, and DASH score 40.4, with an average strength of 4.3 lb in abduction and of 3.3 lb in ER1 and 3.2 lb in ER2 was observed. Radiographically, it was noted that greater tuberosity healing rate was 37 % in hemiarthroplasty group compared to 84 % in reverse arthroplasty group. About complications, the highest rate was recorded in the hemiarthroplasty group. The authors concluded reverse shoulder arthroplasty indication is steadily increasing in acute displaced proximal humeral fracture. Pain and articular movement results appear better than those with hemiarthroplasty. Atalar et al (2014) examined the radiological and clinical short term results of the patients who underwent RSA for rotator cuff arthropathy. The study included 14 (2 male, 12 female) patients who underwent RSA for rotator cuff arthropathy between 2009 and 2010. The mean age of the patients was 74 (57-80) years and the mean follow-up period was 32 (21-40) months. Radiological methods as well as the range of motion, Quick DASH, Constant and VAS scores were used for the evaluation of patients preoperatively and at last the follow-up. Mean active forward flexion, abduction and external rotation increased respectively from 44, 41 and 21 degrees preoperatively to 149, 105 and 37 degrees at the last follow-up. The mean Quick- Dash score was 59.1 degrees preoperatively, and 36.1 degrees at the last follow-up visit. The mean Constant score increased from 20.7 preoperatively to 58.9 at the last follow-up visit. The mean VAS score decreased from 7 preoperatively to 1.2 at the last follow-up visit. The mean acromion-humeral head distance increased from 5.3 mm preoperatively to 23.1 mm postoperatively. None of the patients had major complications. The authors concluded RSA in patients with advanced stage rotator cuff tear arthropathy ensure significant improvement in terms of pain and function with the help of an appropriate rehabilitation protocol. Valenti et al (2013) evaluated the clinical and radiological outcomes of a series of 30 reverse shoulder prostheses performed as revision of failed hemi- or total shoulder arthroplasty in a retrospective study. Thirty patients (average age 69.5) were included. Mean follow-up was 36.4 months (range 24-100 months). There were 14 patients in group 1 (Delta III) and 16 in group 2 (Reverse Arrow). A total of 83 % were satisfied (16 cases) or very satisfied (9 cases), and 17 % were disappointed (5 patients). The mean Constant score increased from a mean of 25-52. The mean score for pain improved from 5 (range 0-15) to 13 (range 5-15) (p < 0.001). The mean score of strength improved from 1 (range 0-6) to 5 (range 0-10) (p < 0.001). The forward elevation changed from a mean of 55 (range 0-120) to 108 (range 40-160) (p < 0.001). There was no significant improvement of external rotation at 0 abduction (range 14-18 ) or internal rotation (range 5-4.63). There were 4 scapular notching. Complication rate was 26.6 %. The authors concluded RSA represents an available option in difficult cases of failed hemiarthroplasty or total shoulder arthroplasty when the rotator cuff is irreparable and the glenoid bone stock is sufficient. Shoulder Arthroplasty Sep 15 8
Muh et al (2013) reported RSA is an accepted treatment that provides reproducible results in the treatment of shoulder arthritis and rotator cuff deficiency. Concerns over the longevity of the prosthesis have resulted in this procedure being reserved for the elderly. There are limited data in the literature with regard to outcomes in younger patients. The authors reported on the early outcomes of RSA in a group of patients who were sixty years or younger and who were followed for a minimum of two years. A retrospective multicenter review of sixty-six patients (sixty-seven RSAs) with a mean age of 52.2 years was performed. The indications included rotator cuff insufficiency (twenty-nine), massive rotator cuff disorder with osteoarthritis (eleven), failed primary shoulder arthroplasty (nine), rheumatoid arthritis (six), posttraumatic arthritis (four), and other diagnoses (eight). Forty-five shoulders (67%) had at least one prior surgical intervention, and thirty-one shoulders (46%) had multiple prior surgical procedures. At a mean follow-up time of 36.5 months, mean active forward elevation of the arm as measured at the shoulder improved from 54.6 to 134.0 and average active external rotation improved from 10.0 to 19.6. A total of 81% of patients were either very satisfied or satisfied. The mean American Shoulder and Elbow Surgeons (ASES) score and visual analog scale (VAS) score for pain improved from 40.0 to 72.4 and 7.5 to 3.0, respectively. The ability to achieve postoperative forward arm elevation of at least 100 was the only significant predictor of overall patient satisfaction (p < 0.05) that was identified in this group. There was a 15% complication rate postoperatively, and twenty-nine shoulders (43%) had evidence of scapular notching at the time of the latest followup. The authors concluded RSA as a reconstructive procedure improved function at the time of short-term follow-up in our young patients with glenohumeral arthritis and rotator cuff deficiency. Objective outcomes in our patient cohort were similar to those in previously reported studies. However, overall satisfaction was much lower in this patient population (81%) compared with that in the older patient population as reported in the literature (90% to 96%). Sershorn et al (2014) reported that RSA has been indicated primarily for patients aged older than 65 years with symptomatic rotator cuff deficiency, poor function, and pain. However, conditions that benefit from RSA are not restricted to an elderly population. This study also evaluated a consecutive series of RSA patients aged younger than 60 years. 36 shoulders (mean age, 54 years) at a mean follow-up of 2.8 years (range, 24-48 months) were evaluated. Of these shoulders, 30 (83%) had previous surgery, averaging 2.5 procedures per patient. The preoperative conditions compelling RSA were as follows: failed rotator cuff repair (12), fracture sequelae (11), failed arthroplasty (5), instability sequelae (4), cuff tear arthropathy (CTA) (4), and rheumatoid arthritis (2). Follow-up examinations included range-ofmotion and strength testing, as well as Single Assessment Numeric Evaluation, visual analog scale, Simple Shoulder Test, American Shoulder and Elbow Surgeons (ASES), and Constant scores. Preoperative and postoperative radiographs were reviewed for component loosening and scapular notching. Failure criteria were defined as undergoing revision, having gross loosening, or having an ASES score below 50. The mean Single Assessment Numeric Evaluation score improved from 24.4 to 72.0; the visual analog scale pain score improved from 6 to 2.1. The Simple Shoulder Test score improved from 1.4 to 6.2, and the ASES score improved from 31.4 to 65.8. Active forward elevation improved from 56 to 121. The normalized postoperative mean Constant score was 54.3. In 9 patients (25.0%), the authors recorded an ASES score below 50, and these cases were considered failures. The authors concluded RSA can improve shoulder function in a younger, complex patient population with poor preoperative functional ability. This study's success rate was Shoulder Arthroplasty Sep 15 9
75% at 2.8 years. This is a limited-goals procedure, and longer-term studies are required to determine whether similar results are maintained over time. Scientific Rationale Update August 2012 There are two types of total shoulder joint prostheses. The standard shoulder prosthesis, the anatomic shoulder prosthesis, conforms to the anatomical shoulder design. In reverse shoulder arthroplasty (RSA), the shoulder prosthesis is a reverse ball and socket design. This design moves the center of glenohumeral joint rotation medial and distal compared with the anatomic center of rotation. The positioning increases deltoid moment, improving the deltoid muscle s control over humeral motion. Thus the deltoid muscle may compensate for lost rotator cuff musculature capacity. Some examples of reverse shoulder prostheses approved per the FDA, include but is not limited to, the Delta shoulder prosthesis (DePuy Inc.), Aequalis Reversed Shoulder Prosthesis (Tounier), Encore Reverse Shoulder Prosthesis (Encore Medical L.P.), Anatomical Shoulder Inverse/Reverse (Zimmer Inc.), Zimmer Trabecular Metal Reverse Shoulder System (Zimmer Inc.), Equinoxe Reverse Shoulder System (Exactech Inc.) and Equinoxe Reverse Shoulder System Fracture Humeral (Exactech Inc.). According to the American Academy of Orthopaedic Surgeons (AAOS), a reverse total shoulder replacement may be recommended when the patient has: A completely torn rotator cuff that cannot be repaired Cuff tear arthropathy A previous shoulder replacement that was unsuccessful Severe shoulder pain and difficulty lifting the arm away from the side or over the head Severe shoulder pain unresponsive to other treatments, such as rest, medications, cortisone injections, and physical therapy The AAOS states further that early studies of the results of reverse shoulder arthroplasty have been very promising, but currently no long-term studies exist. The AAOS notes this is an area for future research. Although the results of reverse total shoulder arthroplasty have been generally favorable, the complication rate appears to be higher than that of conventional total shoulder arthroplasty. Complications include those common to other shoulder procedures (infection, instability, and nerve injury) and those unique to reverse total shoulder arthroplasty (scapular notching, glenoid baseplate failure, component disassociation, and scapular stress fractures). Hattrup et al (2012) carried out a retrospective review of 19 shoulders treated with reverse shoulder prostheses at a mean follow-up of 37 months. The authors rated patients' pain using a visual analog pain scale (VAPS) and noted active range of motion in forward elevation, abduction, and external rotation. American Shoulder and Elbow Society and Simple Shoulder Test SST scores were available for 12 patients preoperatively and 16 postoperatively. We graded final results using the modified Neer scale. Preoperatively, the mean VAPS was 6.5, with average flexion of 68, abduction 66, and external rotation 23. The American Shoulder and Elbow Society score averaged 27 and the SST 1. Postoperatively, the VAPS was 1 and flexion was 138, abduction 134, and external rotation 52. The mean ASES score increased to 76 and the SST to 8. There were 12 excellent, 5 satisfactory, and 2 unsatisfactory results. Complications included 2 scapular spine fractures, 1 acromial Shoulder Arthroplasty Sep 15 10
fracture, 1 dislocation, and 1 ulnar neuropathy. Authors found scapular notching in 42% of the shoulders. Six shoulders had grade 1 notching, and 2 shoulders grade 2 notching. There was no evidence of glenoid loosening, but complete bone-cement radiolucency around 2 cemented stems was observed. Authors concluded at early follow-up, reverse shoulder arthroplasty for the shoulder damaged by inflammatory arthritis and with a deficient rotator cuff can provide noteworthy improvement for most patients. Favard et al (2012) sought to evaluate the rate of complications and the functional improvement with different types of shoulder arthroplasties after a minimum followup of 8 years in a multicenter retrospective study. The study evaluated 198 shoulders including 85 primary osteoarthritis of the shoulder, 76 cuff tear arthropathies, 19 avascular necrosis and 18 rheumatoid arthritis. Arthroplasties included 104 anatomic total shoulder arthroplasties (TSA), 77 reverse arthroplasties (RSA) and 17 hemiarthroplasties. Ten patients had their arthroplasty 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 osteoarthritis of the shoulder, there were eight complications (11%) including six (8.3%) requiring implant revision. In the group of rotator cuff arthropathies, there were nine (14.7%) complications including four (6.5%) requiring implant revision. In the group with rheumatoid arthritis, there was one complication, and no surgical revision was necessary. There were no complications in the group with avascular necrosis. Glenoid migration occurred in 28.5% of anatomic TSA, and 3.4% of reverse arthroplasties. This difference was significant (P<0.001). The Constant-Murley score was significantly improved in all etiologies. Investigators concluded glenohumeral arthropathies can be successfully treated by arthroplasty. Anatomic TSA was shown to be associated with a high risk of glenoid loosening at radiographic follow-up, and thus made the authors hesitant to use the cemented polyethylene implant, especially in young patients. Patel et al (2012) examined initial experience using reverse total shoulder arthroplasty (TSA) as a treatment for failed shoulder arthroplasty. During a 5-year period, 31 patients (mean age, 68.7 years) underwent reverse TSA for treatment of a failed shoulder arthroplasty and their presurgical and operative data were analyzed. Of the 31 patients, 28 were available for an average follow-up of 40.7 months. Their outcomes were assessed with American Shoulder and Elbow Surgeons (ASES), University of California-Los Angeles (UCLA), and Simple Shoulder Test (SST) scores, and the visual analog scale (VAS) for pain. Compared with preoperative status, there were statistically significant improvements in all outcome measurements, including the ASES (24.0 to 66.2), UCLA (7.4 to 23.5), SST (1.5 to 7.6), and VAS (7.0 to 2.6). Active forward elevation improved from 44 preoperatively to 108 postoperatively (P <.001). Results were rated as good or excellent by 19 patients (67.9%), satisfactory by 4 (14.3%), and unsatisfactory by 5 (17.8%). Among the types of failed arthroplasty, patients with failed TSA noted the greatest improvement in their outcome, but this improvement was not statistically significant. Investigators concluded the data suggest that patients can expect improved functional outcome and decreased pain after revision of previous arthroplasty to reverse TSA and that this procedure can provide a reliable salvage option for a challenging clinical problem. Kelly et al (2012) reported the success of revision shoulder arthroplasty using an unconstrained prosthesis depends on an intact rotator cuff and satisfactory bone Shoulder Arthroplasty Sep 15 11
quantity. However, the reverse shoulder arthroplasty can stabilize a glenohumeral joint even in patients with rotator cuff deficiency and bone deficits, resulting in improved outcomes. Thirty shoulders in 28 patients with a failed arthroplasty were investigated consecutively between 2005 and 2008. All shoulders had significant rotator cuff deficiency without glenoid bone loss. Revision arthroplasty using the reverse prosthesis was performed with a minimum of 2 years of follow-up. Concomitant glenoid reconstructions with tricortical iliac crest bone grafting were necessary in 12 shoulders. The average adjusted Constant score improved from 24% to 65% and the American Shoulder and Elbow Surgeons (ASES) score improved from 55 to 72 (P <.0001). Average active forward flexion increased from 42 to 106 (P <.0001). The average ASES pain score improved from 6.6 to 1.6 (P <.0001). The overall complication rate was 50%, and 7 patients (23%) required reoperation. Overall, 24 of 30 shoulders (80%) were very satisfied or satisfied. Investigators concluded reverse shoulder arthroplasty can be an efficacious salvage procedure in the management of failed arthroplasty due to rotator cuff-related instability or bone defects, or both. Structural bone grafting on the glenoid side is successful at managing large defects, producing similar or better clinical outcomes compared with patients without bone loss. Although the operation is associated with a considerable complication rate, 80% of patients were satisfied with the results of the procedure, and 29 of 30 shoulders had a stable prosthesis. Melis et al (2012) evaluated whether, in case of aseptic glenoid loosening and failure in anatomical total shoulder arthroplasty (TSA), revision by a reverse shoulder arthroplasty (RSA) is a reliable therapeutic option in a retrospective multicenter cohort study. Included in the study was 37 consecutive anatomical TSA revised by RSA for aseptic glenoid loosening or failure. The decision to implant a RSA was related to the presence of associated complications: rotator cuff tears (n = 24), subscapularis insufficiency (n = 29), prosthetic instability (n = 13), and glenoid bone deficiency (n = 37). The patients were reviewed clinically and radiographically at a mean follow-up of 47 months (range, 24-104). Eighty-six percent of the patients were satisfied or very satisfied. The average Constant score increased from 24 to 55 pts (P <.0001) and active anterior elevation from 68 to 121 (P <.0001). Twentytwo of the 29 (76%) associated bone grafts were incorporated in the glenoid. Eight patients (21%) needed a subsequent reoperation because of recurrent or new complications: glenoid loosening (n = 3), prosthetic anterior instability (n = 3), and humeral subsidence (n = 2); the reverse prosthesis had to be converted to a hemiarthroplasty in 1 patient and removed in another. Authors concluded revision with a RSA is a reliable therapeutic option which provides the double benefit of glenoid bone stock reconstruction by fixing the bone graft with the help of the baseplate and screws and of solving the problem of soft tissue insufficiency and prosthetic instability. However, surgeons should be aware that the rate of postoperative complications and subsequent reoperations is high, and that the surgical technique is demanding. Leung et al (2012) compared their outcomes for hemiarthroplasty with those for reverse TSA. The records of patients with the diagnosis of rotator cuff tear arthropathy (CTA) who had received either a hemiarthroplasty or reverse TSA from 1997 to 2007 were reviewed. A minimum of 2 years' follow-up was required. Active shoulder elevation, external rotation, internal rotation, and Shoulder Pain and Disability Index (SPADI) scores were obtained. Statistical analysis was performed comparing function, pain, and range of motion of hemiarthroplasty patients with reverse TSA patients. They identified 56 shoulder arthroplasties in 50 patients with a minimum of 2 years' follow-up. There were 20 hemiarthroplasties and 36 reverse Shoulder Arthroplasty Sep 15 12
TSAs performed. The mean follow-up was 4.4 years (range, 2-12 years) in the hemiarthroplasty group and 3 years (range, 2-5 years) in the RSA group. The mean age in the hemiarthroplasty group was 64 years versus 72 years in the RSA group (P <.05). SPADI scores improved in both groups. However, after follow-up of 2 years or greater, the mean SPADI scores were significantly better (lower) in the RSA group (34) than in the hemiarthroplasty group (58) (P =.005). Active elevation was significantly better in the RSA group at all postoperative time periods. The complication rate for both groups was 25%. Investigators concluded RSA performs better than hemiarthroplasty in terms of pain relief, function, and active elevation at 2-year follow-up. Walker et al (2012) evaluated the outcomes of patients with failed total shoulder arthroplasty (TSA) who were treated with conversion to reverse shoulder arthroplasty (RSA) in a retrospective case series of 24 consecutive patients with failed TSA treated with conversion to RSA. Twenty-two patients (16 women, 6 men) had a minimum 2-year clinical and radiographic follow-up. The average age at the time of revision was 68 years (range, 51-84 years). Indications for conversion to RSA included failure of TSA from glenohumeral instability in 19, mechanical failure of the humeral or glenoid component in 10, and infection in 2. The median total American Shoulder and Elbow Surgeons score improved from 38.5 preoperatively to 67.5 (P <.001). Visual analog scale pain scores decreased from 5 to 1.5 (P <.001), and function improved from 2 to 6.5 (P <.001). The median Simple Shoulder Test improved from 1 to 5 (P =.006). Forward flexion improved from 50 to 130 (P <.001), abduction from 45 to 100 (P <.001), and external rotation from 12.5 to 49.5 (P =.056). Internal rotation improved from a spinal level of S2 to L3 (P =.064). Fourteen patients rated their outcome as excellent, 3 as good, 3 as satisfactory, and 2 as unsatisfactory. The overall complication rate was 22.7% (5 of 22). Investigators concluded RSA can be an effective treatment for failed TSA by decreasing pain and improving shoulder function. However, RSA in the revision setting is associated with a higher complication rate Scientific Rationale Update December 2010 Surgical treatment including shoulder arthroplasty is a treatment option for patients with advanced osteoarthritis of the shoulder who have failed conservative treatment. Singh et al. (2010) completed a study to determine the benefit and harm of surgery in patients with osteoarthritis of the shoulder confirmed on X-ray who do not respond to analgesics and NSAIDs. The Cochrane Central Register of Controlled Trials (CENTRAL), via The Cochrane Library was searched as well as OVID MEDLINE; CINAHL (via EBSCOHost); OVID SPORTdiscus; EMBASE; and Science Citation Index (Web of Science). All randomized clinical trials (RCTs) or quasi-randomized trials including adults with osteoarthritis of the shoulder joint (PICO- patients) comparing surgical techniques (total shoulder arthroplasty, hemiarthroplasty, implant types and fixation- intervention) versus placebo or sham surgery, non-surgical modalities, no treatment, or comparison of one type of surgical technique to another (comparison) with patient-reported outcomes (pain, function, quality of life etc.) or revision rates (outcomes). The authors reviewed titles and abstracts for inclusion, extracted study and outcomes data and assessed the risk of bias of included studies. For categorical outcomes, we calculated the risk ratio (with 95% confidence interval (CI)) and for continuous outcomes, the mean difference (95% CI). Seven studies (238 patients) were included for analyses. None of the studies compared shoulder surgery to sham surgery, non-surgical modalities or placebo. Two studies compared hemiarthroplasty to total shoulder arthroplasty; three compared keeled and pegged humeral components; and one each compared navigation surgery to conventional and all- Shoulder Arthroplasty Sep 15 13
polyethylene to metal-backed implant. Two studies (88 patients) compared hemiarthroplasty to total shoulder arthroplasty. Patients who underwent hemiarthroplasty had statistically significantly worse functional scores on American Shoulder and Elbow Surgeons Shoulder Scale (100 point scale; higher = better) at 24 to 34 month follow-up compared to those who underwent total shoulder arthroplasty (mean difference, -10.05; 95% CI, -18.97 to -1.13; 2 studies, 88 patients), but no statistically significant differences between hemiarthroplasty and TSA were noted for pain scores (mean difference, 7.8; 95% CI, -5.33 to 20.93; 1 study, 41 patients), quality of life on short-form 36 physical component summary (mean difference, 0.80; 95% CI, -6.63 to 8.23; 1 study, 41 patients) and adverse events (Risk ratio, 1.19; 95% CI, 0.37 to 3.81; 1 study, 41 patients), respectively. A non-statistically significant trend towards higher revision rate in hemiarthroplasty compared to total shoulder arthroplasty was noted (Risk ratio, 6.18; 95% CI, 0.77 to 49.52; 2 studies, 88 patients; P = 0.09). Total shoulder arthroplasty seems to offer an advantage in terms of shoulder function, with no other clinical benefits over hemiarthroplasty. More studies are needed to compare clinical outcomes of surgery using different components and techniques in patients with osteoarthritis of the shoulder. There is a need for studies comparing shoulder surgery to sham, placebo and other non-surgical treatment options. Scientific Rationale Update August 2007 Per the American Academy of Orthopedic Surgeons (AAOS), approximately 23,000 people have total shoulder replacement yearly. This compares to more than 700,000 Americans who have knee and hip replacement surgery annually. Although the major indication for shoulder arthroplasty is arthritis, there are additional reasons for this type of surgery. Per the AAOS, these would include all of the following: Rotator cuff arthropathy Patients with a massive long-standing rotator cuff tear may develop cuff tear arthropathy. In this injury, the changes in the shoulder joint due to the rotator cuff tear may lead to arthritis and destruction of the joint cartilage. Avascular necrosis Avascular necrosis is a condition in which the bone of the humeral head dies due to lack of blood supply. Chronic steroid use, deep sea diving, severe fracture of the shoulder, sickle cell disease and heavy alcohol use are risk factors for avascular necrosis. A failed shoulder prosthesis This could result from a previous shoulder joint replacement. Scientific Rationale Initial Degenerative disease is a common cause of shoulder pain and dysfunction. Osteoarthritis (OA) is a frequent cause of the degeneration. It is characterized by progressive wearing away of the cartilage of the joint. Other causes of degeneration include rheumatoid arthritis (RA), a systemic condition that causes an inflammation Shoulder Arthroplasty Sep 15 14
of the lining of a joint which can destroy the cartilage and bone, avascular necrosis (AVN) of the humeral head, large rotator cuff tendon tears and posttraumatic degeneration that can occur after fractures of the humeral head or neck and moderate blunt trauma (posttraumatic arthritis). Primary glenohumeral osteoarthritis is more common in women and in patients over the age of 60. Symptoms associated with degenerative disease of the glenohumeral joint include shoulder pain and stiffness, which is aggravated by activity and relieved by rest. Occasionally, patients also complain of night pain. The patient presents with local glenohumeral joint line tenderness, swelling anteriorly, loss of range of motion of external rotation and abduction and crepitation. Radiographic studies can easily distinguish degenerative disease from other conditions that present with similar symptoms, such as rotator cuff disease and adhesive capsulitis. Nonsurgical approaches to the management of the degenerative disease include NSAIDs, physical therapy, immunosuppressive drugs, and intra-articular corticosteroids. Total joint replacement has been considered a major breakthrough in the management of degenerative disease. The goal of surgery is relief of pain and restoration of joint function. Hemiarthroplasty or total shoulder replacement is recommended when symptoms associated with degenerative changes in the glenohumeral joint are unresponsive to conservative treatment. The type of surgery performed depends on the condition of the glenoid. A hemiarthroplasty replaces just the humeral head while a total shoulder replacement replaces both the humeral head and the glenoid. Initially, Neer and others developed an unconstrained humeral head replacement for reconstruction of displaced proximal humerus fractures. Later a cemented glenoid component was developed to resurface glenoid irregularities and to provide a better fulcrum in which to seat the humeral head. Currently, several different shoulder prostheses are available with modular designs and humeral-head stem combinations, thus allowing for a better adjustment of the soft-tissue tension. The severity of soft-tissue and bone destruction determines the choice of shoulder prosthesis, especially the condition of the rotator cuff. Patients with irreparable rotator cuff tears and severe glenohumeral arthritis remain a difficult challenge in shoulder surgery. Success rate for total shoulder replacement using the Neer prosthesis is similar to that of total hip or knee replacement, however, it is associated with a higher failure rate in patients with RA under the age of 50. Surgical intervention is medically necessary for most significantly displaced two- to four-part fractures. Treatment of these complex fractures can include open reduction and internal fixation or hemiarthroplasty. Studies have confirmed that the treatment of proximal humeral fractures with humeral head replacement is associated with reliable pain relief as well as good patient satisfaction. Limited studies suggest that the prostheses have reasonable longevity. The major cause of implant failure is implant loosening. Studies suggest that particulate polyethylene debris found in worn implants causes an immune response that is responsible for subsequent loosening of the prosthesis. Increased cellular proliferation to both acrylic and cobalt-chromium has been observed in patients with aseptically loosened prostheses. Other potential post op complications include infection, and thromboembolic disease. Glenoid component loosening continues to be a major factor affecting the long-term survival rate of total shoulder replacements. Radiolucent lines, cement fracture, migration, and loosening requiring revision are common problems with cemented glenoid components. A study of one hundred and forty-seven total shoulder Shoulder Arthroplasty Sep 15 15
arthroplasties, with use of an uncemented glenoid component fixed with screws between 1988 and 1996 were performed in 132 patients with a mean age of 63.3 years. Preoperative diagnoses included osteoarthritis OA in seventy-two shoulders and RA in fifty-five patients. The purpose of this study was to evaluate the results of total shoulder arthroplasty with an uncemented glenoid component and to identify predictors of glenoid component failure. One hundred and forty shoulders in 124 patients were available for follow-up at an average of 7.5 years. The author concluded that the failure rates of the total shoulder arthroplasties in this study were higher than those in previously reported studies of cemented polyethylene components with similar durations of follow-up. Common problems were screw breakage and excessive polyethylene wear, that may lead to additional failures of these uncemented glenoid components in the future. Another study also suggested that the humeral component should be routinely cemented. This was a prospective study of 58 shoulders (49 patients with RA) that had Neer II total shoulder replacement with use of cemented glenoid and press-fit humeral components. After a mean follow up of 9.5 years, 37 shoulders remained in the study, 29 of which remained pain free or with slight discomfort, 4 had discomfort associated with unusual activity and 4 had moderate to severe pain. Radiographs showed loosening in ten shoulders of nine glenoid and nine humeral components but of these only three had significant symptoms. Three loose glenoid components and two loose humeral components required revision. The author concluded that the Neer total shoulder replacement provides reasonable medium to long-term outcome in RA, but recommend that the humeral component should be routinely cemented. The literature suggests that total shoulder arthroplasty and hemiarthroplasty for treatment of primary OA result in good or excellent pain relief, and improvement in function. A prospective, multicenter study evaluated 176 shoulders in 160 patients with primary OA. This study evaluated a single prosthetic design. It included 133 total shoulder replacements and 43 hemiarthroplasties in 98 men and 62 women. There were significant improvements in all evaluated and self-assessed outcome parameters from the preoperative baseline for both procedures. A follow up study of patients age 50 and younger, who had Neer hemiarthroplasties and Neer total shoulder arthroplasties, suggests that alternative methods of treatment should be considered before either hemiarthroplasty or total shoulder arthroplasty is offered to patients aged 50 years or younger. This study was a minimum fifteen-year follow up of sixty-two hemiarthroplasties and twenty-nine total shoulder arthroplasties. Sixteen patients died, and seven were lost to follow-up but all 114 shoulders were included in the survival analysis. Radiographs were available for 53 hemiarthroplasties and 25 total shoulder arthroplasties with a minimum 10- year follow-up. The results were graded by use of a modified Neer result rating system. Among the hemiarthroplasties, there were 6 excellent (10%), 19 satisfactory (30%), and 37 unsatisfactory results (60%). Among total shoulder arthroplasties, there were 6 excellent (21%), 9 satisfactory (31%), and 14 unsatisfactory results (48%). The estimated survival rate for hemiarthroplasty was 82% at 10 years and 75% at 20 years. The estimated survival rate for total shoulder arthroplasty was 97% at 10 years and 84% at 20 years. The authors conclusions from the study were that there is marked long-term pain relief and improvement in motion with shoulder arthroplasty. However, there is a moderate rate of hemiarthroplasty revision for painful glenoid arthritis. Review History Shoulder Arthroplasty Sep 15 16
July 2006 August 2007 December 2010 September 2011 August 2012 February 2013 August 2013 August 2014 September 2015 Medical Advisory Council initial approval Revised policy. Added rotator cuff arthropathy, avascular necrosis, and failed shoulder prosthesis (from a previous joint replacement), to the medical necessity indications in initial policy statement. Update. Added Medicare Table. No revisions. Update. Added Medicare Table. No Revisions. Update no revisions Code Updates Update no revisions. Codes updated. Update Added to policy statement indications when reverse total shoulder arthroplasty may be considered medically necessary Update no revisions. Codes updated. This policy is based on the following evidence-based guideline: 1. American Academy of Orthopedic Surgeons. Shoulder Joint Replacement. October 2007. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=a00094 2. American Academy of Orthopaedic Surgeons (AAOS). The treatment of glenohumeral joint osteoarthritis. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2009 Dec 4. 198 p. Available at: http://www.aaos.org/research/guidelines/gloguideline.asp 3. Hayes Medical Technology Directory. Reverse Shoulder Total Joint Prosthesis. Mar 2008. Updated June 2012. Archived June 2013 4. American Academy of Orthopedic Surgeons. Reverse Total Shoulder Replacement. September 2010. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=a00504 5. Hayes. Medical Technology Directory. Reverse Shoulder Total Joint Prosthesis. September 11, 2014. Updated August 16, 2015. References Update September 2015 1. Erickson BJ, Frank RM, Harris JD, et al. The influence of humeral head inclination in reverse total shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2015 Jun;24(6):988-93. doi: 10.1016/j.jse.2015.01.001. Epub 2015 Feb 26. 2. Florschütz AV, Lane PD, Crosby LA. Infection after primary anatomic versus primary reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Aug;24(8):1296-301. doi: 10.1016/j.jse.2014.12.036. Epub 2015 Feb 19. 3. Gilot G, Alvarez-Pinzon AM, Wright TW, et al. The incidence of radiographic aseptic loosening of the humeral component in reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 May 7. pii: S1058-2746(15)00080-4. doi: 10.1016/j.jse.2015.02.007. [Epub ahead of print] 4. Lópiz Y, Rodríguez-González A, García-Fernández C, et al. Scapula insufficiency fractures after reverse total shoulder arthroplasty in rotator cuff arthropathy: What is their functional impact? Rev Esp Cir Ortop Traumatol. 2015 Sep- Oct;59(5):318-325. doi: 10.1016/j.recot.2015.01.003. Epub 2015 Mar 26. 5. Postacchini R, Carbone S, Canero G, et al. Reverse shoulder prosthesis in patients with rheumatoid arthritis: a systematic review. Int Orthop. 2015 Jul 23. [Epub ahead of print]. 6. Schairer WW, Nwachukwu BU, Lyman S, et al. Reverse shoulder arthroplasty versus hemiarthroplasty for treatment of proximal humerus fractures. J Shoulder Elbow Surg. 2015 May 7. pii: S1058-2746(15)00159-7. doi: 10.1016/j.jse.2015.03.018. [Epub ahead of print]. Shoulder Arthroplasty Sep 15 17
7. Triplet JJ, Everding NG, Levy JC, et al. Functional internal rotation after shoulder arthroplasty: a comparison of anatomic and reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Jun;24(6):867-74. doi: 10.1016/j.jse.2014.10.002. Epub 2014 Dec 2. 8. Wagner ER, Houdek MT, Elhassan BT, et al. What Are Risk Factors for Intraoperative Humerus Fractures During Revision Reverse Shoulder Arthroplasty and Do They Influence Outcomes? Clin Orthop Relat Res. 2015 Jul 11. [Epub ahead of print] 9. Wang J, Zhu Y, Zhang F, et al. Meta-analysis suggests that reverse shoulder arthroplasty in proximal humerus fractures is a better option than hemiarthroplasty in the elderly. Int Orthop. 2015 Jun 24. [Epub ahead of print] References Update September 2014 1. Acevedo DC, Mann T, Abboud JA, et al. Reverse total shoulder arthroplasty for the treatment of proximal humeral fractures: patterns of use among newly trained orthopedic surgeons. J Shoulder Elbow Surg. 2014 Apr 9 2. Al-Hadithy N, Domos P, Sewell MD, Pandit R. Reverse shoulder arthroplasty in 41 patients with cuff tear arthropathy with a mean follow-up period of 5 years. J Shoulder Elbow Surg. 2014 May 29. 3. Alta TD, de Toledo JM, Veeger HE, et al. The active and passive kinematic difference between primary reverse and total shoulder prostheses. J Shoulder Elbow Surg. 2014 Apr 13. 4. Atalar AC, Salduz A, Cil H, Sungur M, et al. Reverse shoulder arthroplasty: radiological and clinical short-term results. Acta Orthop Traumatol Turc. 2014;48(1):25-31. 5. Baudi P, Campochiaro G, Serafini F, et al. Hemiarthroplasty versus reverse shoulder arthroplasty: comparative study of functional and radiological outcomes in the treatment of acute proximal humerus fracture. Musculoskelet Surg. 2014 Mar 23. 6. Black EM, Roberts SM, Siegel E, et al. Reverse shoulder arthroplasty as salvage for failed prior arthroplasty in patients 65 years of age or younger. J Shoulder Elbow Surg. 2014 Jul;23(7):1036-42. 7. Bonnevialle N, Mansat P, Lebon J et al. Reverse shoulder arthroplasty for malignant tumors of proximal humerus. J Shoulder Elbow Surg. 2014 Jun 11 8. Chalmers PN, Slikker W 3rd, Mall NA, Gupta, et al. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reductioninternal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Feb;23(2):197-204 9. Iacobellis C, Berizzi A, Biz C, Camporese A. Treatment of proximal humeral fractures with reverse shoulder arthroplasty in elderly patients. Musculoskelet Surg. 2014 Jun 11 10. Kaa AK, Jørgensen PH, Søjbjerg JO, Johannsen HV. Reverse shoulder replacement after resection of the proximal humerus for bone tumours. Bone Joint J. 2013 Nov;95-B(11):1551-5. 11. Kadum B, Mukka S, Englund E, et al. Clinical and radiological outcome of the Total Evolutive Shoulder System (TESS) reverse shoulder arthroplasty: a prospective comparative non-randomised study. Int Orthop. 2014 May;38(5):1001-6. 12. Kaisidis A, Pantos PG, Heger H, et al. Reverse shoulder arthroplasty for the treatment of three and four part fractures of the proximal humerus in patients older than 75 years old. Acta Orthop Belg. 2014 Mar;80(1):99-105. Shoulder Arthroplasty Sep 15 18
13. Levy JC, Everding NG, Gil CC Jr, Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Jun 26. 14. Mata-Fink A, Meinke M, Jones C, Kim B, Bell JE. Reverse shoulder arthroplasty for treatment of proximal humeral fractures in older adults: a systematic review. Shoulder Elbow Surg. 2013 Dec;22(12):1737-48. 15. Muh SJ, Streit JJ, Wanner JP, et al. Early follow-up of reverse total shoulder arthroplasty in patients sixty years of age or younger. J Bone Joint Surg Am. 2013 Oct 16;95(20):1877-83 16. Sershon RA, Van Thiel GS, Lin EC, et al. Clinical outcomes of reverse total shoulder arthroplasty in patients aged younger than 60 years. J Shoulder Elbow Surg. 2014 Mar;23(3):395-400. 17. Valenti P, Kilinc AS, Sauzières P, Katz D. Results of 30 reverse shoulder prostheses for revision of failed hemi- or total shoulder arthroplasty. Eur J Orthop Surg Traumatol. 2013 Oct 18. References Update August 2013 1. Anderson BC. Glenohumeral osteoarthritis. UpToDate. Updated August 2012. 2. Canale & Beaty: Campbell's Operative Orthopaedics, 12th ed. 2012 Mosby, An Imprint of Elsevier. Part V Reconstructive Procedures of the Shoulder and Elbow in Adults. 3. Carter MJ, Mikuls TR, Nayak S, et al. Impact of total shoulder arthroplasty on generic and shoulder-specific health-related quality-of-life measures: A systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012;94(17):e1271-e1279. 4. Duquin TR, Jacobson JA, Sanchez-Sotelo J, et al. Unconstrained shoulder arthroplasty for treatment of proximal humeral nonunions. J Bone Joint Surg Am. 2012;94(17):1610-1617. 5. Fevang BT, Lygre SH, Bertelsen G, et al. Good function after shoulder arthroplasty. Acta Orthop. 2012;83(5):467-473. 6. Jones LC. Osteonecrosis (avascular necrosis of bone). UpToDate. Updated August 2012. 7. Razmjou H, Holtby R, Christakis M, et al. Impact of prosthetic design on clinical and radiologic outcomes of total shoulder arthroplasty: A prospective study. J Shoulder Elbow Surg. 2012 Jul 20. [Epub ahead of print] 8. Singh JA, Sperling J, Schleck C, et al. Periprosthetic fractures associated with primary total Shoulder arthroplasty and primary humeral head replacement: A thirty-three-year study. J Bone Joint Surg Am. 2012;94(19):1777-1785. 9. Swedish Orthopedic Institute. Shoulder replacement. 2012. Available at: http://www.swedish.org/services/orthopedic-institute/orthopedic- Services/Joint-Replacement/Shoulder-Replacement#axzz26kjKPyTI. References Update August 2012 1. American Academy of Orthopaedic Surgery. Reverse Total Shoulder Replacement. Sept. 2010. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=a00504 2. Affonso J, Nicholson GP, Frankle MA, et al. Complications of the reverse prosthesis: prevention and treatment. Instr Course Lect. 2012;61:157-68. 3. Boyle MJ, Youn SM, Frampton CM, Ball CM. Functional outcomes of reverse shoulder arthroplasty compared with hemiarthroplasty for acute proximal humeral fractures. J Shoulder Elbow Surg. 2012 May 29. 4. Favard L, Katz D, Colmar M, et al. Total shoulder arthroplasty - Arthroplasty for glenohumeral arthropathies: Results and complications after a minimum follow- Shoulder Arthroplasty Sep 15 19
up of 8years according to the type of arthroplasty and etiology. Orthop Traumatol Surg Res. 2012 Jun;98(4 Suppl):S41-7. 5. Hattrup SJ, Sanchez-Sotelo J, Sperling JW, Cofield RH. Reverse Shoulder Replacement for Patients With Inflammatory Arthritis. J Hand Surg Am. 2012 Jun 30. 6. Kelly JD 2nd, Zhao JX, Hobgood ER, Norris TR. Clinical results of revision shoulder arthroplasty using the reverse prosthesis. J Shoulder Elbow Surg. 2012 Feb 22. 7. Lenarz C, Shishani Y, McCrum C, et al. Is reverse shoulder arthroplasty appropriate for the treatment of fractures in the older patient? Early observations. Clin Orthop Relat Res. 2011 Dec;469(12):3324-31. 8. Leung B, Horodyski M, Struk AM, Wright TW. Functional outcome of hemiarthroplasty compared with reverse total shoulder arthroplasty in the treatment of rotator cuff tear arthropathy. J Shoulder Elbow Surg. 2012 Mar;21(3):319-23. 9. Melis B, Bonnevialle N, Neyton L, et al. Glenoid loosening and failure in anatomical total shoulder arthroplasty: is revision with a reverse shoulder arthroplasty a reliable option? J Shoulder Elbow Surg. 2012 Mar;21(3):342-9. 10. Patel DN, Young B, Onyekwelu I, et al. Reverse total shoulder arthroplasty for failed shoulder arthroplasty. J Shoulder Elbow Surg. 2012 Feb 21. 11. Sadoghi P, Vavken P, Leithner A, et al. Impact of previous rotator cuff repair on the outcome of reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2011 Oct;20(7):1138-46. 12. Singh JA, Sperling J, Buchbinder R, McMaken K. Surgery for shoulder osteoarthritis: a Cochrane systematic review. J Rheumatol. 2011 Apr;38(4):598-605 13. Smithers CJ, Young AA, Walch G. Reverse shoulder arthroplasty. Curr Rev Musculoskelet Med. 2011 Dec;4(4):183-90. 14. Walker M, Willis MP, Brooks JP, et al. The use of the reverse shoulder arthroplasty for treatment of failed total shoulder arthroplasty. J Shoulder Elbow Surg. 2012 Apr;21(4):514-22. 15. Young AA, Smith MM, Bacle G, Moraga C, Walch G. Early results of reverse shoulder arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg Am. 2011 Oct 19;93(20):1915-23. References Update September 2011 1. Baddour LM,. Sexton DJ. Clinical manifestations and diagnosis of prosthetic joint infections. UpToDate. March 22, 2011. 2. Helfgott SM. Evaluation and medical management of end-stage rheumatoid arthritis. UpToDate. February 10, 2011. References Update December 2010 1. Armitage MS, Faber KJ, Drosdowech DS, et al. Humeral Head Bone Defects: Remplissage, Allograft, and Arthroplasty. Orthopedic Clinics of North America. Volume 41, Issue 3 (July 2010). 2. Nguyen KHY, Weisman MH. Total joint replacement for severe rheumatoid arthritis. UpToDate. May 2010. 3. Singh JA, Sperling J, Buchbinder R, et al. Surgery for shoulder osteoarthritis. Cochrane Database Syst Rev. 2010 Oct 6. 4. Rasaul AT, Wright J. Total Joint Replacement Rehabilitation. January 20, 2010. 5. DeLee: DeLee and Drez's Orthopaedic Sports Medicine, 3rd ed. 2009. Simulated Shoulder ARTHROPLASTY USING A MODEL. Shoulder Arthroplasty Sep 15 20
6. Elkousy HA, Edwards TB. DeLee: DeLee and Drez's Orthopaedic Sports Medicine, 3rd ed. 2009 Saunders, An Imprint of Elsevier. SECTION Q, Development of Skills for Shoulder Surgery. References - Update August 2007 1. Shoulder Replacement Surgery ("Shoulder Arthroplasty"). MD Consult. 2007. References - Initial 1. Schill S, Thabe H, Grifka J. Differential therapy for the rheumatoid shoulder Orthopade. 2002 Dec;31(12):1132-44. 2. Sperling JW, Cofield RH, Rowland CM. Neer hemiarthroplasty and Neer total shoulder arthroplasty in patients fifty years old or less. Long-term results. J Bone Joint Surg Am. 1998 Apr;80(4):464-73. 3. Gill DR, Cofield RH, Morrey BF. Ipsilateral total shoulder and elbow arthroplasties in patients who have rheumatoid arthritis. J Bone Joint Surg Am. 1999 Aug;81(8):1128-37. 4. Norris TR, Iannotti JP. Functional outcome after shoulder arthroplasty for primary osteoarthritis: a multicenter study. J Shoulder Elbow Surg. 2002 Mar- Apr;11(2):130-5. 5. Collins DN, Harryman DT 2nd, Wirth MA. Shoulder arthroplasty for the treatment of inflammatory arthritis. J Bone Joint Surg Am. 2004 Nov;86-A(11):2489-96. 6. Murphy LA, Prendergast PJ. Acromion-fixation of glenoid components in total shoulder arthroplasty. J Biomech. 2005 Aug;38(8):1702-11. 7. Mengshoel AM, Slungaard B. Effects of shoulder arthroplasty and exercise in patients with rheumatoid arthritis. Clin Rheumatol. 2005 Jun;24(3):258-65. Epub 2004 Nov 26. 8. Martin SD, Zurakowski D, Thornhill TS. Uncemented glenoid component in total shoulder arthroplasty. Survivorship and outcomes. J Bone Joint Surg Am. 2005 Jun;87(6):1284-92. 9. Boyd, AD Jr, Thornhill, TS. Surgical treatment of osteoarthritis of the shoulder. Rheum Dis Clin North Am 1988; 14:591. 10. Up to Date. Glenohumeral osteoarthritis. April 2005. Accessed June 2005. 11. Terrier A, Buchler P, Farron A. et al. Bone-cement interface of the glenoid component: Stress analysis for varying cement thickness. Clin Biomech (Bristol, Avon). 2005 Jun 13. 12. Up to Date. Total joint replacement for severe rheumatoid arthritis. April 2005, Accessed June 2005. 13. Stewart, MP, Kelly, IG. Total shoulder replacement in rheumatoid disease: 7- to 13-year follow-up of 37 joints. J Bone Joint Surg Br 1997; 79:68. 14. Lehtinen, JT, Kaarela, K, Belt, EA, et al. Incidence of glenohumeral joint involvement in seropositive rheumatoid arthritis. A 15 year endpoint study. J Rheumatol 2000; 27:347. 15. Lyman S, Sherman S, Dunn WR, et al. Advancements in the surgical and alternative treatment of arthritis. Curr Opin Rheumatol. 2005 Mar;17(2):129-33. 16. Pokorny D, Sosna A, Vavrik P, et al. Shoulder arthroplasty in traumatological indications, long-term results. Acta Chir Orthop Traumatol Cech. 2004;71(5):272-6. 17. Plausinis D, Kwon YW, Zuckerman JD. Complications of humeral head replacement for proximal humeral fractures. Instr Course Lect. 2005;54:371-80. 18. Kwon YW, Zuckerman JD. Outcome after treatment of proximal humeral fractures with humeral head replacement. Instr Course Lect. 2005;54:363-9. Shoulder Arthroplasty Sep 15 21
19. Phipatanakul WP, Norris TR. Indications for prosthetic replacement in proximal humeral fractures. Instr Course Lect. 2005;54:357-62. 20. Mansat P, Guity MR, Bellumore Y, et al. Shoulder arthroplasty for late sequelae of proximal humeral fractures. J Shoulder Elbow Surg. 2004 May-Jun;13(3):305-12. 21. Kumar S, Sperling JW, Haidukewych GH, et al. Periprosthetic humeral fractures after shoulder arthroplasty. J Bone Joint Surg Am. 2004 Apr;86-A(4):680-9. 22. Up to Date. Proximal humerus fractures in adults. April 2005. Accessed June 2005 23. Laudicina L, D'Ambrosia R. Management of irreparable rotator cuff tears and glenohumeral arthritis. Orthopedics. 2005 Apr;28(4):382-8; quiz 389-90. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary Shoulder Arthroplasty Sep 15 22
depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Shoulder Arthroplasty Sep 15 23