Shoulder Arthroplasty Policy Notes

Shoulder Arthroplasty Medical Policy

Introduction

• Shoulder arthroplasty involves surgery to replace the shoulder joint with metal and plastic parts.
• A common reason is severe pain from overuse, limiting daily activities.
• May involve replacing only the shoulder head (ball) or reversing the implanted parts (reverse shoulder arthroplasty).
• The policy outlines the circumstances under which shoulder arthroplasty is considered medically necessary.
• The introduction is for general knowledge only and not policy coverage criteria.
• The policy uses specific medical terms intended for healthcare providers (doctors, nurses, psychologists, dentists, hospitals, clinics, or labs) to inform them about service coverage.

Policy Coverage Criteria

• The policy covers total shoulder arthroplasty, reverse shoulder arthroplasty, shoulder hemiarthroplasty, and revision shoulder arthroplasty.

Total Shoulder Arthroplasty - Medical Necessity

Total shoulder arthroplasty may be considered medically necessary for joint disease when ALL of the following criteria are met:

• Documented diagnosis of one of the following:
  • Degenerative joint disease (DJD)
  • Osteoarthritis (OA)
  • Rheumatoid arthritis (RA)
  • Traumatic arthritis
  • Avascular necrosis
• Treatment is needed due to one or more of the following:
  • Disabling pain for at least 3 months duration
  • Functional disability interfering with activities of daily living for at least 3 months duration
• Radiographic or imaging evidence (X-ray, CT, MRI) of destructive degenerative joint disease of the shoulder in the 12 months prior to surgery, as evidenced by ONE or more of the following:
  • Irregular joint surfaces
  • Glenoid sclerosis
  • Glenoid osteophyte changes
  • Flattened glenoid
  • Cystic changes in the humeral head
  • Joint space narrowing
• Documentation of three months of failed non-operative conservative management, demonstrated by a trial of one or more of the following:
  • Anti-inflammatory medications or analgesics
  • Intra-articular injection of corticosteroids as appropriate
• A 6-week trial of one or more of the following physical measures under the direction of a healthcare professional:
  • Physical therapy
  • Activity modification
  • Flexibility and muscle strengthening exercises

OR

Total shoulder arthroplasty may be considered medically necessary for ANY of the following conditions:

• Proximal humerus fracture malunion or non-union
• Reconstruction after tumor resection of the glenohumeral joint or surrounding tissue
• Failed hemi-arthroplasty
• Post-traumatic injury (e.g., fracture, infection) causing shoulder joint destruction

Reverse Total Shoulder Arthroplasty - Medical Necessity

Reverse total shoulder arthroplasty may be considered medically necessary when there is an intact deltoid muscle, at least 90 degrees of passive shoulder range of motion (elevation/flexion), and adequate bone stock to support an implant, and when ALL of the following criteria are met:

• Advanced joint disease of the shoulder is present, confirmed by radiologic imaging or arthroscopic findings in the 12 months prior to surgery, and at least ONE of the following conditions is present:
  • Glenohumeral osteoarthritis with irreparable rotator cuff tear
  • Pseudo paralysis from an irreparable rotator cuff tear (inability to actively elevate the arm)
  • Massive rotator cuff tear arthropathy (> 5 cm)
  • Avascular necrosis or osteonecrosis of the humeral head without glenoid involvement
• Treatment is needed due to one or more of the following:
  • Disabling pain for at least 3 months duration
  • Functional disability interfering with activities of daily living for at least 3 months duration
• Documentation of three months of failed non-operative conservative management, demonstrated by a trial of one or more of the following:
  • Anti-inflammatory medications or analgesics
  • Intra-articular injection of corticosteroids as appropriate
• A 6-week trial of one or more of the following physical measures under the direction of a healthcare professional:
  • Physical therapy
  • Activity modification
  • Flexibility and muscle strengthening exercises

OR

Reverse shoulder arthroplasty may be considered medically necessary for ANY of the following conditions:

• Shoulder fracture that is not repairable and cannot be reconstructed with other techniques
• Reconstruction required after a tumor resection
• Failed hemi-arthroplasty
• Failed total shoulder arthroplasty with non-repairable rotator cuff tear

Shoulder Hemiarthroplasty - Medical Necessity

Shoulder hemiarthroplasty may be considered medically necessary when ALL of the following criteria are met:

• Advanced joint disease of the shoulder is present, and at least ONE of the following conditions is present:
  • Glenohumeral osteoarthritis with irreparable rotator cuff tear
  • Glenoid bone stock inadequate to support a glenoid prosthesis
  • Osteonecrosis of the humeral head without glenoid involvement
  • Radiographic or imaging evidence (e.g., X-ray, CT, MRI) of destructive degenerative joint disease of the shoulder in the 12 months prior to surgery as evidenced by ONE or more of the following:
    • Irregular joint surfaces
    • Glenoid sclerosis
    • Glenoid osteophyte changes
    • Flattened glenoid
    • Cystic changes in the humeral head
    • Joint space narrowing
• Treatment is needed due to one or more of the following:
  • Disabling pain for at least 3 months duration
  • Functional disability interfering with activities of daily living for at least 3 months duration
• Documentation of three months of failed non-operative conservative management, demonstrated by a trial of one or more of the following:
  • Anti-inflammatory medications or analgesics
  • Intra-articular injection of corticosteroids as appropriate
• A 6-week trial of one or more of the following physical measures under the direction of a healthcare professional:
  • Physical therapy
  • Activity modification
  • Flexibility and muscle strengthening exercises

OR

Shoulder hemiarthroplasty may be considered medically necessary for ANY of the following conditions:

• Proximal humerus fracture not amenable to internal fixation
• Tumor involving the glenohumeral joint or surrounding soft tissue requiring reconstruction

Revision/Replacement Shoulder Arthroplasty - Medical Necessity

A revision shoulder arthroplasty may be considered medically necessary as indicated by ONE or more of the following:

• Aseptic loosening of one or more prosthetic components confirmed by imaging
• Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction
• Component instability
• Displaced periprosthetic fracture
• Fracture, mechanical failure, or recall of a prosthetic component
• Migration of the humeral head
• Periprosthetic infection
• Recurrent prosthetic dislocation
• Persistent shoulder pain of unknown etiology unresponsive to non-operative conservative care for 6 months

Surgery - Not Medically Necessary

• Total shoulder, reverse total shoulder, or hemi-arthroplasty is considered not medically necessary when the above medical necessity criteria are not met.
• Total shoulder, reverse total shoulder, or hemi-arthroplasty is considered not medically necessary when ANY of the following are present:
  • Active infection of the joint or active systemic bacteremia
  • Active skin infection or open wound within the planned surgical site
  • Allergy to components of the implant (e.g., cobalt, chromium, stainless steel, titanium, etc.)
  • Deltoid deficiency (e.g., axillary nerve palsy)
  • Inadequate bone stock to support implantation of prosthesis
  • Neuropathic (Charcot) arthropathy of the shoulder
  • Paralytic disorder of the shoulder (e.g., flail shoulder due to irreversible brachial plexus palsy, spinal cord injury)
  • Rapidly progressive neurological disease

Documentation Requirements

The individual’s medical records submitted for review for all conditions should document that medical necessity criteria are met for the procedure requested. The record should include the following:

• For a total shoulder arthroplasty and degenerative joint disease such as osteoarthritis or rheumatoid arthritis or traumatic arthritis or osteonecrosis ALL of the following are present:
  • Needs treatment because of disabling pain and/or limited shoulder function interfering with activities of daily living (ADLs) AND
  • Imaging evidence of destructive degenerative joint disease of the shoulder in the 12 months prior to surgery as evidenced by one or more of the following: irregular joint surfaces, glenoid sclerosis, glenoid osteophyte changes, flattened glenoid, cystic changes in the humeral head or joint space narrowing AND
  • History of unsuccessful three-month trial of failed non-operative conservative management of one or more of the following medications: anti-inflammatory drugs or analgesics, or intra-articular injection of corticosteroids as appropriate, and a 6 week trial of one or more of the following physical measures under the direction of a healthcare professional: physical therapy, or flexibility and muscle strengthening exercises, or reasonable restriction of activities.
• For other conditions, detailed clinical documentation supporting the diagnosis of one of the following:
  • Proximal humerus fracture malunion or non-union
  • Reconstruction after tumor resection of the glenohumeral joint or surrounding tissue
  • Failed hemi-arthroplasty
  • Post-traumatic injury (e.g., fracture, infection) causing shoulder joint destruction
• For replacement/revision of previous arthroplasty with evidence of one of the following:
  • Aseptic loosening of one or more prosthetic components confirmed by imaging
  • Bearing surface wear leading to symptomatic synovitis or local bone or soft tissue reaction
  • Component instability
  • Displaced periprosthetic fracture
  • Fracture, mechanical failure, or recall of a prosthetic component
  • Migration of the humeral head
  • Periprosthetic infection
  • Recurrent prosthetic dislocation
  • Persistent shoulder pain of unknown etiology unresponsive to non-operative conservative care for 6 months
• For a reverse total shoulder arthroplasty when there is an intact deltoid muscle, there is at least 90 degrees of passive shoulder range of motion (elevation/flexion), and there is adequate bone stock to support an implant along with ANY of the following: shoulder fracture that is not repairable and cannot be reconstructed with other techniques, reconstruction after a tumor resection, failed hemi-arthroplasty, failed total shoulder arthroplasty with non-repairable rotator cuff tear OR
• Advanced joint disease of the shoulder is present and confirmed by radiologic imaging or arthroscopic findings in the 12 months prior to surgery and at least ONE of the following conditions is present: glenohumeral osteoarthritis with irreparable rotator cuff repair, or pseudo paralysis from an irreparable rotator cuff tear (inability to actively elevate the arm), or massive cuff tear arthropathy (> 5 cm), or avascular necrosis or osteonecrosis of the humeral head without glenoid involvement AND
  • Needs treatment because of disabling pain and/or limited shoulder function interfering with activities of daily living (ADLs) AND
  • History of unsuccessful three-month trial of failed non-operative conservative management of one or more of the following medications: anti-inflammatory drugs or analgesics, or intra-articular injection of corticosteroids as appropriate, and a 6 week trial of one or more of the following physical measures under the direction of a healthcare professional: physical therapy, or flexibility and muscle strengthening exercises, or reasonable restriction of activities.
• For a shoulder hemiarthroplasty one of the following conditions is present:
  • Proximal humerus fracture not amenable to internal fixation
  • Tumor involving the glenohumeral joint or surrounding soft tissue requires reconstruction OR
• Advanced joint disease of the shoulder is present and at least ONE of the following conditions is present:
  • Glenohumeral osteoarthritis with irreparable rotator cuff tear
  • Glenoid bone stock inadequate to support a glenoid prosthesis
  • Osteonecrosis of the humeral head without glenoid involvement
  • Radiographic or imaging evidence (e.g., X-ray, CT, MRI) of destructive degenerative joint disease of the shoulder in the 12 months prior to surgery as evidenced by one or more of the following:
    • Irregular joint surfaces
    • Glenoid sclerosis
    • Glenoid osteophyte changes
    • Flattened glenoid
    • Cystic changes in the humeral head
    • Joint space narrowing
  • AND
  • Needs treatment because of disabling pain and/or limited shoulder function interfering with activities of daily living (ADLs) AND
  • History of unsuccessful three-month trial of failed non-operative conservative management of one or more of the following medications: anti-inflammatory drugs or analgesics, or intra-articular injection of corticosteroids as appropriate, and a 6 week trial of one or more of the following physical measures under the direction of a healthcare professional:
    • Physical therapy, or flexibility and muscle strengthening exercises, or reasonable restriction of activities.

Coding

• Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
• HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Evidence Review

Description

• Total shoulder arthroplasty (replacement) (aka anatomic shoulder arthroplasty) is a surgical procedure in which damaged bone and cartilage is removed from the glenohumeral joint and replaced with artificial implant (prosthetic) components made usually of metal and plastic.
• The head of the humerus is replaced with a ball component and the glenoid surface is replaced with a socket component.
• Reverse shoulder arthroplasty, as the name implies, reverses the implant components. The ball component is attached to the shoulder blade and the socket component is attached to the upper arm bone. This procedure is usually performed when the rotator cuff is severely damaged.
• Hemiarthroplasty (partial arthroplasty) is a procedure where only the ball component (the humeral head) is replaced with an artificial implant component, the glenoid is left intact.
• The goal of these procedures is to reduce pain and secondarily to restore mobility and function of the shoulder in order for an individual to return to an activity level as close to normal as possible.

Background

• Shoulder arthroplasty (replacement) has become a common surgical procedure for joint replacement due to joint degeneration leading to pain and functional impairment that is not improved by conservative medical management such as non-steroidal anti-inflammatories, injections of corticosteroids, or physical therapy.
• It is considered the gold standard for treatment for shoulder disorders such as osteoarthritis, rheumatoid arthritis, complex fractures, avascular necrosis, and rotator cuff arthropathy.
• The prevalence of shoulder arthroplasty in the US has increased from $0.031$% in 1995 to $0.083$% in 2005 according to the National Inpatient Sample query taken from 1988 to 2017.
• In 2017 an estimated 823,361 individuals were living in the US with a shoulder replacement. This represents a prevalence of $0.258$%, which is projected to continue to grow to 174,000 to 350,000 shoulder replacement procedures annually by 2025.
• Currently, it is estimated that more than 100,000 individuals have shoulder replacement surgery each year.
• Glenohumeral osteoarthritis, one of the main indications for shoulder joint degeneration, occurs more commonly in women and increases with age, especially over age 60.
• The shoulder is made up of three bones: the humerus (upper arm bone), the scapula (the shoulder blade) and the clavicle (collar bone).
• Like the hip joint, the shoulder is a ball and socket joint. The ball, or the head of the upper arm bone fits into the socket of the shoulder blade, called the glenoid.
• When the articular cartilage covering these bones becomes damaged one of the types of shoulder arthroplasty described above may be needed.

Indications for Shoulder Arthroplasty

• Osteoarthritis of the shoulder is a condition that usually occurs in individuals over the age of 55. It is usually brought on by wear-and tear of the shoulder joint when the cartilage that cushions the bones of the shoulder wears down. This wearing down of the cartilage causes the bones to rub against one another which leads to the development of pain in that area.
• Rheumatoid arthritis of the shoulder is a disorder where the synovial membrane (the tissue that helps lubricate the cartilage surrounding the shoulder joints and allows for easy movement of the joints), becomes inflamed. When this inflammation is chronic, it can damage the cartilage bringing about pain and stiffness.
• Traumatic arthritis is a condition that can occur after a major shoulder injury. It may stem from a fracture, dislocation, or tears of the shoulder tendons or ligaments. These injuries can also lead to damage to the cartilage bringing on pain and limiting shoulder functionality.
• Avascular necrosis (osteonecrosis) occurs when there is a loss of blood supply to the shoulder bones which causes the bones to die and leads to destruction of the shoulder joints. Common causes for avascular necrosis are long-term steroid use, heavy alcohol use, sickle cell anemia, fracture, and radiation therapy. It is more common in individuals between the ages of 30 and 50.
• A severe fracture or multiple fractures of the shoulder may be difficult to treat and put back together. A fracture(s) may also lead to disruption of the blood supply to the affected bones. This condition may best be treated with a shoulder replacement.
• A tumor(s) requiring resection of the affected shoulder is also a condition which may require a shoulder replacement.
• Rotator cuff tear arthropathy is a condition that develops from a very large tear or from the long-term presence of a tear that leads to arthritis and destruction of the shoulder joint cartilage requiring the shoulder joint to be replaced as the tear itself was not able to be repaired. This condition is best treated with a reverse shoulder replacement.
• Failed previous shoulder replacement surgery may require a revision shoulder replacement due to implant loosening, wearing down of the implant components, fracture around the prosthetic component, infection, instability, or dislocation.

Summary of Evidence

• Singh et al (2010) in a Cochrane review of seven studies (238 individuals) concluded that total shoulder arthroplasty seems to offer an advantage in terms of shoulder function over hemiarthroplasty.
• Sandow et. al (2013) concluded with 10 years of follow-up that total shoulder arthroplasty (n=20) was better at pain relief and function at 2 years postoperatively (P <.02) than hemiarthroplasty (n=13). However, there were no statistically significant differences found between the two groups with respect to pain, function, and daily activities at 10 years.
• Ernstbrunner et al (2019) concluded that reverse total shoulder arthroplasty for massive irreparable rotator cuff tears showed significant improvement of overhead function and subjective and objective long term outcome scores up to 20 years postoperatively based on their pooled long-term results.
• Davies et al (2022) concluded that the current literature does not support that revision of a shoulder hemiarthroplasty may lead to improved outcomes compared to revision of a total shoulder arthroplasty. This conclusion was reached after review of 15 studies (12 were case series and 3 were cohort studies) which reported on 593 revision anatomical shoulder replacements of which 557 reached the final follow-up period. The primary procedure was a total shoulder arthroplasty in 11 of the studies and a hemiarthroplasty in 4 studies.

Ongoing and Unpublished Clinical Trials

Some currently ongoing trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

• NCT: national clinical trial.

Practice Guidelines and Position Statements

• The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the policy conclusions.
• Guidelines or position statements will be considered for inclusion if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE).
• Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Orthopaedic Surgeons (AAOS)

• In 2020, the AAOS updated clinical practice guideline for management of glenohumeral joint osteoarthritis recommendation states that there is strong evidence that supports total shoulder arthroplasty demonstrates more favorable function and pain relief in the short-to mid-term compared to hemiarthroplasty for the treatment of glenohumeral osteoarthritis.
• It was the opinion of the work group that individuals with glenohumeral osteoarthritis undergoing arthroplasty should be imaged with axillary and true AP radiographs. Advanced imaging should be performed at the discretion of the clinician.
• It was the opinion of the work group that either total shoulder arthroplasty or reverse shoulder arthroplasty be used for the treatment of glenohumeral osteoarthritis with excessive bone loss and/or rotator cuff dysfunction.

National Institute for Health and Care Excellence (NICE)

• In 2020 the NICE guideline for joint replacement (primary) elective shoulder replacement made the following recommendation:
  • If glenoid bone is adequate, a total shoulder replacement for treatment of osteoarthritis with no rotator cuff tear should be offered.
• The committee was unable to make a recommendation for shoulder replacement for pain and loss of function for individuals with a previous proximal humeral fracture.

Medicare National Coverage

• There is no national coverage determination.

Regulatory Status

• Shoulder arthroplasty procedures are surgical procedures and as such, are not subject to regulation by the FDA. Several implants and instruments used during the surgery require FDA approval.
• Product codes for these devices include: KWS, KWT, MBF, PAO, PHX, PKC, QHE.

History

• 09/10/24: New policy, approved September 10, 2024, effective for dates of service on or after January 3, 2025, following 90-day provider notification. Total shoulder arthroplasty, reverse total shoulder arthroplasty, and shoulder hemiarthroplasty may be considered medically necessary when criteria are met. Add to Surgery section.
• 03/01/25: Annual Review, approved February 10, 2025. Policy reviewed. No references added. Some policy criteria reorganized for consistency, otherwise policy statements unchanged, policy intent unchanged.
• 06/01/25: Interim Review, approved May 12, 2025. Minor edits made to policy statements for greater clarity. Policy intent unchanged.