Latest Review Date: June 2023

Category:  Surgery                                                                 

POLICY

Shoulder resurfacing, including total, hemi, or partial resurfacing, is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE

Resurfacing the shoulder joint is a method to treat painful shoulders without replacing the humeral head.  Humeral resurfacing can be conducted together with or without resurfacing of the glenoid.  This policy addresses partial or complete resurfacing of the humerus, and resurfacing of both the humerus and glenoid.

Resurfacing of the humeral head can be accomplished with devices that provide either complete or partial coverage, and may be performed alone (hemi-resurfacing: HR) or in combination with glenoid resurfacing (total shoulder resurfacing: TSR).  With TSR, the glenoid is resurfaced with similar implants and procedures as are currently used for total shoulder arthroplasty.  Biologic resurfacing of the glenoid with meniscal allograft or other biologic tissue has also been reported, but is outside of the scope of the present policy.

The objective of resurfacing is to preserve the individual patient’s normal head-neck anatomy and bone stock.  Prostheses that are used to resurface the humeral head differ from those traditionally used in hemi- or total shoulder arthroplasty by using a small peg that is impact fit through the humeral head/neck in place of a long stem inserted through the bone shaft.  The prosthesis is implanted at the angle of the humeral neck instead of replacing the humeral head and neck.  It has been proposed that in addition to reducing intraoperative blood loss and the occurrence of humeral periprosthetic fractures, resurfacing arthroplasty may avoid technical errors in version, head height, offset, and neck-shaft angle.  It has also been proposed that resurfacing will improve revisions, since removal of stemmed implants are associated with tuberosity and shaft fractures that can lead to implant instability, proximal humerus bone loss, and poor shoulder function. In addition, the larger head size may lead to improved clinical outcomes.  This policy therefore focuses on the impact of these design changes on clinical outcomes related to pain and function, as well as the long-term effects of resurfacing related to implant stability and durability in comparison with total shoulder or hemiarthroplasty.

Several prosthetic designs are currently available in the US. Developed by Copeland and colleagues, the Mark prosthesis is currently in its 3rd generation in Europe.  The Copeland™ Mark 1 had a central pegged humeral component which was secured with a screw, and a polyethylene glenoid element that was stabilized by a peg.  The Mark-2 prosthesis, which was introduced in 1990 in Europe, added a metal backing to the glenoid component and a fluted tapered peg to both components.  The Mark-3 model, used since 1993, has a hydroxyapatite coating to improve bone ingrowth.  Three sizes of the prosthesis are available. Copeland™ Extended Articulating Surface (EAS)™  Resurfacing Heads (Biomet Manufacturing) were cleared by the US Food and Drug Administration (FDA) through the 510(k) process in 2005.  They are indicated for “hemi- or total shoulder replacement in patients with massive, irreparable rotator cuff tears and arthritis.  Specific indications include cuff tear arthropathy and difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.”  The glenoid component may be used for total shoulder resurfacing (both humerus and glenoid resurfaced) or total shoulder arthroplasty (humeral head replacement with glenoid resurfacing).  The DePuy Global CAP™ CTA Resurfacing Shoulder Humeral Head (DePuy), cleared for marketing by the FDA in 2008, has the same indications as the Copeland device and lists an earlier model of the DePuy Global CAP and the Copeland EAS among predicate devices.  The Axiom Shoulder Resurfacing System (Axiom Orthopaedics) was cleared for marketing by the FDA in 2006 for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain; non-inflammatory degenerative joint disease (i.e., osteoarthritis and avascular necrosis); correction of functional deformity; fractures of the humeral head; traumatic arthritis.  The Durom® cup (Zimmer, Switzerland) and the EPOCA RH Cup (Argo Medical, Switzerland) have not received clearance for marketing in the US.

A partial resurfacing implant for the shoulder, known as the HemiCAP® (Arthrosurface), was cleared for marketing in 2003 under the name Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing Prosthesis (STD Manufacturing).

KEY POINTS

Summary of Evidence

Shoulder resurfacing has the potential to improve pain and function to the same extent as total shoulder replacement or hemiarthroplasty, while at the same time reducing risks from the surgical procedure, preserving bone stock and reducing the difficulty with revision procedures.  At this time, however, evidence in support of these proposed benefits is limited/lacking.  For some implant designs, the published literature consists of one small case series.  The 4 independent case series identified on the Copeland prosthesis suggest better short-term outcomes with total shoulder resurfacing or total shoulder arthroplasty than humeral head resurfacing alone.  This is similar to findings of recent systematic reviews that compared hemiarthroplasty with total shoulder arthroplasty; the choice of these two procedures remains controversial due to the differing effects on glenoid erosion and glenoid component loosening.  For shoulder resurfacing, questions remain about the stability and durability of these prostheses, as well as the effect of partial or total humeral resurfacing on the glenoid.  Controlled studies are needed to evaluate the risks and benefits of hemi- and total shoulder resurfacing in comparison with hemi- and total shoulder replacement. Several clinical trials are in progress, with estimated completion dates of 2013.  At the present time, evidence is insufficient to permit conclusions concerning the effect of this procedure on health outcomes.  Therefore, partial resurfacing, humeral resurfacing and total shoulder resurfacing are considered investigational.

KEY WORDS:

Resurfacing, shoulder, total shoulder, Mark-3, Mark-1, Mark-2, Copeland Extended Articulating Surface (EAS) Resurfacing Heads, DuPuy Global Cap, Axiom Shoulder Resurfacing System

APPROVED BY GOVERNING BODIES:

Copeland™ Extended Articulating Surface (EAS)™  Resurfacing Heads (Biomet Manufacturing)—FDA 510(k) approval July 7, 2005

DePuy Global CAP™ CTA Resurfacing Shoulder Humeral Head (DePuy)—FDA 510(k) approval June 8, 2008

Axiom Shoulder Resurfacing System (Axiom Orthopaedics)—FDA 510(k) approval July 6, 2006

HemiCAP® (Arthrosurface) (Contoured Articular Prosthetic (CAP) Humeral Head Resurfacing Prosthesis)—FDA 510(k) approval January 10, 2003

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CODING: 

CPT Codes:    

There are no CPT codes specific to resurfacing of the shoulder.  In the absence of a specific code, the preferable code to use would be the CPT code for unlisted procedure of the shoulder (23929).

Codes 23470 and 23472 should not be used to report this procedure.

REFERENCES:

1. Bryant D, Litchfield R, Sandow M, et al.  A comparison of pain, strength, range of motion, and functional outcomes after hemiarthroplasty and total shoulder arthroplasty in patients with osteoarthritis of the shoulder.  A systematic review and meta-analysis.  J Bone Joint Surg Am 2005; 87(9):1947-56.
2. Buchner M, Eschbach N and Loew M.  Comparison of the short-term functional results after surface replacement and total shoulder arthroplasty for osteoarthritis of the shoulder: A matched-pair analysis.  Arch Orthop Trauma Surg 2008; 128(4):347-54.
3. Burgess DL, et al.  Shoulder resurfacing.  Journal of Bone and Joint Surgery 2009; 91: 1228-1238.
4. ClinicalTrials.gov Available at: http://www.clinicaltrials.gov/ct2/results?term=shoulder+resurfacing.  Last viewed May 2009.
5. Crowther MA, et al.  Neuropathic shoulder in syringomyelia treated with resurfacing arthroplasty of humeral head and soft-tissue lining of glenoid:  A case report.  Journal of Shoulder Elbow Surgery, November/December 2007, Vol. 16, No. 6.
6. Fuerst M, Fink B and Rüther W.  The DUROM cup humeral surface replacement in patients with rheumatoid arthritis.  J Bone Joint Surg Am 2007; 89(8):1756-62.
7. Geervliet PC, van den Bekerom MPJ, Spruyt P, et al. Outcome and revision rate of uncemented glenohumeral resurfacing (C.A.P.) after 5-8 years. Arch Orthop Trauma Surg. 2017;137(6):771-778.
8. Ibrahim EF, Rashid A, Thomas M. Resurfacing hemiarthroplasty of the shoulder for patients with juvenile idiopathic arthritis. J Shoulder Elbow Surg. 2018;27(8):1468-1474.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Lee KT, et al.  Cementless surface replacement arthroplasty of the shoulder with biologic resurfacing of the glenoid.  Journal of Shoulder Elbow Surgery 2009, Vol. 18, pp. 915-919.
11. Levy O and Copeland SA.  Cementless surface replacement arthroplasty of the shoulder. 5- to 10-year results with the Copeland mark-2 prosthesis.  J Bone Joint Surg Br 2001; 83(2):213-21.
12. Levy O and Copeland SA.  Cementless surface replacement arthroplasty (Copeland CSRA) for osteoarthritis of the shoulder.  J Shoulder Elbow Surg 2004; 13(3):266-71.
13. Levy O, Funk L, Sforza G, et al.  Copeland surface replacement arthroplasty of the shoulder in rheumatoid arthritis.  J Bone Joint Surg Am 2004; 86-A(3):512-8.
14. Lollino N, Pellegrini A, Paladini P, et al. Gleno-Humeral arthritis in young patients: clinical and radiographic analysis of humerus resurfacing prosthesis and meniscus interposition. Musculoskelet Surg. 2011;95(1):59-63.
15. National Institute for Health and Care Excellence (NICE). Shoulder resurfacing arthroplasty. July 2010. Available at: http://www.nice.org.uk/guidance/ipg354/evidence/shoulder-resurfacingarthroplasty-interventional-procedures-overview. Accessed February 7, 2016.
16. Pritchett J: Long-term results and patient satisfaction after shoulder resurfacing. J Shoulder Elbow Surg. 2011;20(5):771-777.
17. Radnay CS, Setter KJ, Chambers L, et al.  Total shoulder replacement compared with humeral head replacement for the treatment of primary glenohumeral osteoarthritis: A systematic review.  J Shoulder Elbow Surg 2007; 16(4):396-402.
18. Schmidutz F, Sprecher CM, Milz S, et al. Resurfacing of the humeral head: An analysis of the bone stock and osseous integration under the implant. J Orthop Res. 2015;33(9):1382-1390.
19. Soudy K, Szymanski C, Lalanne C, et al. Results and limitations of humeral head resurfacing: 105 cases at a mean follow-up of 5 years. Orthop Traumatol Surg Res. 2017;103(3):415-420.
20. Sweet SJ, Takara T, Ho L, Tibone JE. Primary partial humeral head resurfacing: Outcomes with the HemiCAP implant. Am J Sports Med. 2015;43(3):579-587.
21. Thomas SR, Wilson AJ, Chambler A, et al.  Outcome of Copeland surface replacement shoulder arthroplasty.  J Shoulder Elbow Surg 2005; 14(5):485-91.
22. Uribe JW and Bemden AB.  Partial humeral head resurfacing for osteonecrosis.  J Shoulder Elbow Surg 2009 Jan 29 [Epub ahead of print].

POLICY HISTORY:

Medical Policy Group, July 2009 (3)

Medical Policy Administration Committee, August 2009

Available for comment August 10-September 23, 2009

Medical Policy Group, November 2009 (3)

Medical Policy Group, November 2010 (1) No changes to policy, Statement added to Key Points

Medical Policy Group, March 2012: Effective March 12, 2012 Active policy but no longer scheduled for regular literature reviews and update.

Medical Policy Group, October 2019 (7): Reviewed by consensus. Updates to References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2021 (7): Reviewed by consensus. Updates to References. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Removed “not medically necessary” verbiage from Policy Statement. No change in intent.

Medical Policy Group, July 2022 (7): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2023 (7): Reviewed by consensus. Updates to Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.