LCD L39956: Total Shoulder Arthroplasty

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.

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